Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA Approvals

Premarket Approval devices tracked by MedTracker

PMA 2016-12-21

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Ventana Medical Systems, Inc.

PMA Number P160002

Class 3

View Details →

PMA 2016-12-21

Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Applicant Corin USA

PMA Number P050016

Class 3

View Details →

PMA 2016-12-20

Telescope, implantable, miniature

Applicant Samsara Vision, Inc.

PMA Number P050034

Class 3

View Details →

PMA 2016-12-20

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

Applicant Mentor Worldwide, LLC

PMA Number P060028

Class 3

View Details →

PMA 2016-12-20

Implant, cochlear

Applicant Med-El Corp.

PMA Number P000025

Class 3

View Details →

PMA 2016-12-20

Sensor, glucose, invasive, non-adjunctive

Applicant Dexcom, Inc.

PMA Number P120005

Class 3

View Details →

PMA 2016-12-20

Pump, infusion, implanted, programmable

Applicant Medtronic, Inc.

PMA Number P860004

Class 3

View Details →

PMA 2016-12-19

Acid, hyaluronic, intraarticular

Applicant Seikagaku Corp.

PMA Number P080020

Class 3

View Details →

PMA 2016-12-19

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

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P850089

Class 3

View Details →

PMA 2016-12-19

implantable pacemaker Pulse-generator

Applicant Biotronik, Inc.

PMA Number P950037

Class 3

View Details →

PMA 2016-12-19

CATHETER, CORONARY, ATHERECTOMY

Applicant Boston Scientific Corp

PMA Number P900056

Class 3

View Details →

PMA 2016-12-19

Sensor, glucose, invasive

Applicant Medtronic Minimed

PMA Number P980022

Class 3

View Details →

Page 42 of 78

↑