Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 2026-10-16

Pump, infusion, implanted, programmable

Applicant Medtronic, Inc.

PMA Number P860004

Class 3

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PMA 2026-10-16

implantable pacemaker Pulse-generator

Applicant Biotronik, Inc.

PMA Number P950037

Class 3

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PMA 2026-10-16

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

Applicant Medtronic Cardiac Rhythm Disease Management

PMA Number P030036

Class 3

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PMA 2026-10-16

Lenses, soft contact, extended wear

Applicant Vistakon, Division of Johnson & Johnson Vision Car

PMA Number P040045

Class 3

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PMA 2026-10-16

STENT, SUPERFICIAL FEMORAL ARTERY

Applicant Medtronic Vascular, Inc.

PMA Number P110023

Class 3

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PMA 2026-10-16

Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Applicant Zimmer, Inc.

PMA Number P060037

Class 3

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PMA 2026-10-16

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant Biotronik, Inc.

PMA Number P050023

Class 3

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PMA 2026-10-16

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

Applicant Biotronik, Inc.

PMA Number P070008

Class 3

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PMA 2026-10-16

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant Biotronik, Inc.

PMA Number P000009

Class 3

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PMA 2026-10-16

Automated external defibrillators (non-wearable)

Applicant ZOLL Medical Corporation

PMA Number P160022

Class 3

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PMA 2026-10-16

Coronary drug-eluting stent

Applicant Medtronic Vascular

PMA Number P160043

Class 3

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PMA 2026-10-16

Stent, carotid

Applicant Medtronic Vascular, Inc.

PMA Number P060001

Class 3

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