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 2020-12-18

Osseoanchored prostheses for the rehabilitation of transfemoral amputees

Applicant Integrum AB

PMA Number P190009

Class 3

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PMA 2020-12-18

Pulmonary valve prosthesis percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P200015

Class f

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PMA 2020-12-17

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Boston Scientific Corporation

PMA Number P170023

Class 3

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PMA 2020-12-17

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Bolton Medical, Inc.

PMA Number P190015

Class 3

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PMA 2020-12-16

Automated external defibrillators (non-wearable)

Applicant Philips Medical Systems

PMA Number P180028

Class 3

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PMA 2020-12-16

Automated external defibrillators (non-wearable)

Applicant Philips Medical Systems, Inc.

PMA Number P160028

Class 3

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PMA 2020-12-16

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Boston Scientific Corporation

PMA Number P190019

Class 3

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PMA 2020-12-10

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Roche Molecular Systems, Inc.

PMA Number P190028

Class 3

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PMA 2020-12-09

Stimulator, bone growth, non-invasive

Applicant Theragen, Inc.

PMA Number P190030

Class 3

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PMA 2020-11-24

Joint, temporomandibular, implant

Applicant Stryker Leibinger, GmbH & Co KG

PMA Number P980052

Class 3

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PMA 2020-11-24

intraocular lens

Applicant Alcon Laboratories, LLC

PMA Number P190018

Class 3

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PMA 2020-11-13

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

Applicant Ventana Medical Systems, Inc.

PMA Number P190031

Class 3

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