FDA PMA Approvals

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant Boston Scientific Corp

PMA Number P010012

Class 3

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Natera, Inc.

PMA Number P260004

Class 3

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant ABBOTT MEDICAL

PMA Number P220013

Class 3

SYSTEM, TEST, HER-2/NEU, IHC

Applicant Ventana Medical Systems, Inc.

PMA Number P990081

Class 3

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P010031

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P830060

Class 3

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant St Jude Medical

PMA Number P130026

Class 3

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Bard Peripheral Vascular, Inc.

PMA Number P070014

Class 3

Intracranial aneurysm flow diverter

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

PMA Number P100018

Class 3

implantable pacemaker Pulse-generator

Applicant Biotronik, Inc.

PMA Number P950037

Class 3

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Applicant Ventana Medical Systems, Inc.

PMA Number P190031

Class 3

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Abbott Molecular, Inc.

PMA Number P230003

Class 3

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant Boston Scientific

PMA Number P960006

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P910073

Class 3

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant Boston Scientific

PMA Number P960004

Class 3

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Applicant Medtronic, Inc.

PMA Number P240013

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P910077

Class 3

Implant, dermal, for aesthetic use

Applicant Q-Med AB

PMA Number P140029

Class 3

Wearable automated external defibrillator

Applicant Zoll Manufacturing Corporation

PMA Number P010030

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P930035

Class 3

intraocular lens

Applicant Alcon Laboratories, LLC

PMA Number P190018

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P980016

Class 3

Implantable pulse generator, pacemaker (non-CRT)

Applicant Boston Scientific

PMA Number P150012

Class 3

Tricuspid valve repair device, percutaneously delivered

Applicant ABBOTT MEDICAL

PMA Number P230007

Class 3

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant W. L. Gore & Associates, Inc.

PMA Number P020004

Class 3

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant W. L. Gore and Associates, Inc.

PMA Number P200030

Class 3

Implant, dermal, for aesthetic use

Applicant Merz North America, Inc.

PMA Number P050052

Class 3

Ventricular (assist) bypass

Applicant Medtronic

PMA Number P100047

Class 3

Mitral valve repair devices

Applicant ABBOTT MEDICAL

PMA Number P100009

Class 3

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P980035

Class 3

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Biotronik Nro, Inc.

PMA Number P210037

Class 3

Implantable pulse generator, pacemaker (non-CRT)

Applicant Medtronic, Inc.

PMA Number P010015

Class 3

Implant, dermal, for aesthetic use

Applicant Merz North America, Inc.

PMA Number P050037

Class 3

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Merz North America, Inc.

PMA Number P040047

Class 3

Device, hemostasis, vascular

Applicant Cordis US Corporation

PMA Number P040044

Class 3

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Medtronic Neuromodulation

PMA Number P840001

Class 3

Implantable pulse generator

Applicant Impulse Dynamics (Usa), Inc.

PMA Number P180036

Class 3

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Boston Scientific Corp

PMA Number P030017

Class 3

Iliac covered stent, arterial

Applicant Atrium Medical Corp.

PMA Number P120003

Class 3

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Applicant Medtronic, Inc.

PMA Number P240013

Class 3

Stimulator, tibial, electrical, implantable, for urinary incontinence

Applicant Medtronic Neuromodulation

PMA Number P240011

Class 3

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant Medtronic, Inc.

PMA Number P960009

Class 3

Coronary drug-eluting stent

Applicant Medtronic Vascular

PMA Number P160043

Class 3

Stimulator, bone growth, non-invasive

Applicant Theragen, Inc.

PMA Number P190030

Class 3

Stimulator, electrical, implanted, for parkinsonian symptoms

Applicant Boston Scientific Corp

PMA Number P150031

Class 3

Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation

Applicant TransMedics, Inc.

PMA Number P160013

Class 3

System, hemodynamic, implantable

Applicant ABBOTT MEDICAL

PMA Number P100045

Class 3

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation

Applicant TransMedics, Inc.

PMA Number P200031

Class 3

Implant, dermal, for aesthetic use

Applicant Tiger Aesthetics Medical, LLC

PMA Number P020012

Class 3

Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing

Applicant Biomet Manufacturing Corp

PMA Number P010014

Class 3

Prosthesis, finger, semi-constrained, metal/polymer

Applicant Keri Medical SA

PMA Number P240020

Class 3

Prosthesis, breast, inflatable, internal, saline

Applicant Mentor Worldwide, LLC

PMA Number P990075

Class 3

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Foundation Medicine, Inc.

PMA Number P170019

Class 3

Implant, dermal, for aesthetic use

Applicant Teoxane S.A.

PMA Number P170002

Class 3

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Medtronic Vascular

PMA Number P100021

Class 3

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P930036

Class 3

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Abbott Laboratories

PMA Number P120008

Class 3

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P250026

Class 3

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Applicant Mentor Corp.

PMA Number P030053

Class 3

Transcatheter septal occluder (atrial)

Applicant Occlutech Holding AG

PMA Number P200032

Class 3

Agent, absorbable hemostatic, collagen based

Applicant Davol Inc., Sub. C. R. Bard, Inc.

PMA Number N17600

Class 3

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Cook Medical Incorporated

PMA Number P140016

Class 3

Transcatheter septal occluder

Applicant W. L. Gore & Associates, Inc.

PMA Number P050006

Class 3

Implant, dermal, for aesthetic use

Applicant Prollenium Medical Technologies, Inc.

PMA Number P160042

Class 3

Leadless pacemaker

Applicant Medtronic, Inc.

PMA Number P150033

Class 3

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Foundation Medicine, Inc.

PMA Number P190032

Class 3

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Foundation Medicine, Inc.

PMA Number P170019

Class 3

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant William Cook Europe Aps

PMA Number P180001

Class 3

Stent, carotid

Applicant Contego Medical, Inc.

PMA Number P240009

Class 3

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant Medtronic, Inc.

PMA Number P960009

Class 3

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Medtronic Neuromodulation

PMA Number P840001

Class 3

Automated external defibrillators (non-wearable)

Applicant Heartsine Technologies, Ltd.

PMA Number P160008

Class 3

Microspheres radionuclide

Applicant Sirtex Medical, Inc.

PMA Number P990065

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Biotronik, Inc.

PMA Number P980023

Class 3

Implanted electrical device intended for treatment of fecal incontinence

Applicant Medtronic Neuromodulation

PMA Number P080025

Class 3

VENTILATOR, HIGH FREQUENCY

Applicant Bunnell, Inc.

PMA Number P850064

Class 3

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM

Applicant DiaSorin, Inc.

PMA Number P250039

Class 3

implantable pacemaker Pulse-generator

Applicant Biotronik, Inc.

PMA Number P950037

Class 3

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant Biotronik, Inc.

PMA Number P050023

Class 3

Stimulator, electrical, implantable, for incontinence

Applicant Medtronic Neuromodulation

PMA Number P970004

Class 3

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Applicant Biotronik, Inc.

PMA Number P070008

Class 3

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant Biotronik, Inc.

PMA Number P000009

Class 3

Valve, pulmonary

Applicant Gyrus Acmi, Inc.

PMA Number P180007

Class 3

Shockwave intravascular lithotripsy system

Applicant Shockwave Medical, Inc.

PMA Number P200039

Class 3

Stent, central venous

Applicant Boston Scientific Corporation

PMA Number P980033

Class 3

STENT, ILIAC

Applicant Boston Scientific Scimed, Inc.

PMA Number P940019

Class 3

Surgical cardiac ablation device, for treatment of atrial fibrillation

Applicant AtriCure, Inc.

PMA Number P100046

Class 3

CATHETER, CORONARY, ATHERECTOMY

Applicant Boston Scientific Corp

PMA Number P900056

Class 3

STENT, ILIAC

Applicant Boston Scientific Corp

PMA Number P110035

Class 3

Automated external defibrillators (non-wearable)

Applicant Physio-Control, Inc.

PMA Number P160026

Class 3

Surgical cardiac ablation device, for treatment of atrial fibrillation

Applicant AtriCure, Inc.

PMA Number P200002

Class 3

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Applicant Farapulse, Inc.

PMA Number P230030

Class 3

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P980035

Class 3

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P180043

Class 3

STENT, ILIAC

Applicant Boston Scientific Corporation

PMA Number P090003

Class 3

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Boston Scientific Corporation

PMA Number P140028

Class 3

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P890003

Class 3

alfapump System

Applicant Sequana Medical NV

PMA Number P230044

Class 3

Ventricular (assist) bypass

Applicant Abbott

PMA Number P170038

Class 3

alfapump System

Applicant Sequana Medical NV

PMA Number P230044

Class 3

stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb

Applicant Neuros Medical, Inc.

PMA Number P230020

Class 3

Ventricular (assist) bypass

Applicant Abbott

PMA Number P170038

Class 3

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number P080011

Class 3

Lenses, soft contact, extended wear

Applicant Vistakon, Division of Johnson & Johnson Vision Car

PMA Number P040045

Class 3

Implant, dermal, for aesthetic use

Applicant Merz North America, Inc.

PMA Number P090016

Class 3

Implanted electrical device intended for treatment of fecal incontinence

Applicant Medtronic Neuromodulation

PMA Number P080025

Class 3

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Guardant Health, Inc.

PMA Number P200010

Class 3

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Medtronic, Inc.

PMA Number P140010

Class 3

Intrasaccular Flow Disruption Device

Applicant MicroVention, Inc.

PMA Number P170032

Class 3

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Applicant Mentor Corp.

PMA Number P030053

Class 3

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Boston Scientific Corporation

PMA Number P190019

Class 3

Drug-coated peripheral transluminal angioplasty catheter

Applicant Medtronic Vascular, Inc.

PMA Number P190008

Class 3

Stimulator, electrical, implantable, for incontinence

Applicant Medtronic Neuromodulation

PMA Number P970004

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P980016

Class 3

Implantable pulse generator, pacemaker (non-CRT)

Applicant Medtronic, Inc.

PMA Number P010015

Class 3

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P980035

Class 3

intraocular lens

Applicant Alcon Laboratories, LLC

PMA Number P190018

Class 3

Implant, cochlear

Applicant Cochlear Americas

PMA Number P970051

Class 3

Prosthesis, breast, noninflatable, internal, silicone gel-filled

Applicant Mentor Corp.

PMA Number P030053

Class 3

Stimulator, spinal-cord, totally implanted for pain relief

Applicant ABBOTT MEDICAL

PMA Number P010032

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic, Inc.

PMA Number P220012

Class 3

Dorsal root ganglion stimulator for pain relief

Applicant ABBOTT MEDICAL

PMA Number P150004

Class 3

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P010031

Class 3

Stimulator, hypoglossal nerve, implanted, apnea

Applicant LivaNova USA, Inc.

PMA Number P250013

Class 3

Stent, vena cava

Applicant W. L. Gore & Associates, Inc.

PMA Number P250017

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P980016

Class 3

Excimer laser system

Applicant Carl Zeiss Meditec, Inc.

PMA Number P060004

Class 3

intraocular lens

Applicant Alcon Laboratories, Inc.

PMA Number P930014

Class 3

Cochlear implant with combined electrical stimulation and acoustic amplification

Applicant Cochlear Americas

PMA Number P130016

Class 3

Leadless pacemaker

Applicant Medtronic, Inc.

PMA Number P150033

Class 3

Implant, auditory brainstem

Applicant Cochlear Americas

PMA Number P000015

Class 3

Aortic valve, prosthesis, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P140031

Class 3

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant ABBOTT MEDICAL

PMA Number P140009

Class 3

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P010031

Class 3

Gases used within eye to place pressure on detached retina

Applicant Airgas Therapeutics, LLC

PMA Number P900066

Class 3

Leadless pacemaker

Applicant Medtronic, Inc.

PMA Number P150033

Class 3

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Roche Diagnostics Corp.

PMA Number P990056

Class 3

Agent, injectable, embolic

Applicant Ev3 Neurovascular

PMA Number P030004

Class 3

Percutaneously Delivered Prostheses and Tricuspid Valves

Applicant Edwards Lifesciences, LLC

PMA Number P230013

Class 3

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant DePuy Orthopaedics, Inc.

PMA Number P070026

Class 3

Agent, absorbable hemostatic, non-collagen based

Applicant Davol, Inc.

PMA Number P050038

Class 3

Lenses, soft contact, extended wear

Applicant Vistakon, Division of Johnson & Johnson Vision Car

PMA Number P040045

Class 3

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Applicant Roche Diagnostics Corp.

PMA Number P000027

Class 2

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic, Inc.

PMA Number P220012

Class 3

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160022

Class 3

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant W. L. Gore & Associates, Inc.

PMA Number P020004

Class 3

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P010031

Class 3

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160033

Class 3

Absorbable collagen hemostatic agent with thrombin

Applicant Dilon Technologies, Inc.

PMA Number P170012

Class 3

Implantable cardioverter defibrillator (non-CRT)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P980016

Class 3