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 2026-09-18

Drug-eluting percutaneous transluminal coronary angioplasty catheter

Applicant MedAlliance, LLC

PMA Number P250041

Class 3

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PMA 2026-09-17

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Cook, Inc.

PMA Number P020018

Class 3

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PMA 2026-09-17

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P910073

Class 3

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PMA 2026-09-17

Implant, dermal, for aesthetic use

Applicant Q-Med AB

PMA Number P030050

Class 3

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PMA 2026-09-17

Prosthesis, intervertebral disc

Applicant Synergy Spine Solutions, Inc.

PMA Number P250028

Class 3

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PMA 2026-09-16

MR-guided focused ultrasound system

Applicant Insightec

PMA Number P150038

Class 3

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PMA 2026-09-16

Filler, bone void, synthetic peptide

Applicant Cerapedics, LLC

PMA Number P140019

Class 3

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PMA 2026-09-16

Prosthesis, intervertebral disc

Applicant Highridge Medical, LLC

PMA Number P110002

Class 3

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PMA 2026-09-16

Prosthesis, intervertebral disc

Applicant Highridge Medical, LLC

PMA Number P110009

Class 3

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PMA 2026-09-16

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

Applicant Foundation Medicine, Inc.

PMA Number P170019

Class 3

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PMA 2026-09-16

Intracranial coil-assist stent

Applicant MicroVention, Inc.

PMA Number P170013

Class 3

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PMA 2026-09-16

Normothermic preservation system for transplantation of initially unacceptable donor lungs

Applicant Xvivo Perfusion, Inc.

PMA Number P180014

Class 3

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