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 2016-12-14

Leadless pacemaker

Applicant Medtronic, Inc.

PMA Number P150033

Class 3

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PMA 2016-12-14

tissue adhesive for use in embolization of brain arteriovenous malformations

Applicant Cerenovus, Inc.

PMA Number P990040

Class 3

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PMA 2016-12-14

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Medtronic Vascular, Inc.

PMA Number P110023

Class 3

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PMA 2016-12-14

System, appendage closure, left atrial

Applicant Boston Scientific Corp

PMA Number P130013

Class 3

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PMA 2016-12-14

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P970012

Class 3

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PMA 2016-12-14

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Roche Diagnostics Corp.

PMA Number P110022

Class 2

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PMA 2016-12-14

Transcervical contraceptive tubal occlusion device

Applicant Bayer Pharma AG

PMA Number P020014

Class 3

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PMA 2016-12-14

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Roche Diagnostics Corp.

PMA Number P110031

Class 2

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PMA 2016-12-14

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Medtronic, Inc.

PMA Number P140010

Class 3

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PMA 2016-12-14

Implantable pulse generator, pacemaker (non-CRT)

Applicant Medtronic, Inc.

PMA Number P090013

Class 3

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PMA 2016-12-14

Cardiac ablation percutaneous catheter

Applicant Medtronic, Inc.

PMA Number P930029

Class 3

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PMA 2016-12-14

Implantable pulse generator, pacemaker (non-CRT)

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P820003

Class 3

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