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 2026-09-10

Device, hemostasis, vascular

Applicant Cardiva Medical, Inc.

PMA Number P120016

Class 3

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PMA 2026-09-10

Ablation catheter, renal denervation

Applicant Medtronic, Inc.

PMA Number P220026

Class 3

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PMA 2026-09-10

Implant, dermal, for aesthetic use

Applicant Merz North America, Inc.

PMA Number P250020

Class 3

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PMA 2026-09-09

Wearable automated external defibrillator

Applicant Zoll Manufacturing Corporation

PMA Number P010030

Class 3

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PMA 2026-09-09

Prosthesis, intervertebral disc

Applicant Centinel Spine, LLC

PMA Number P070001

Class 3

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PMA 2026-09-09

Ventricular (assist) bypass

Applicant ABBOTT MEDICAL

PMA Number P160054

Class 3

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PMA 2026-09-09

Stimulator, tibial, electrical, implantable, for urinary incontinence

Applicant Boston Scientific Corporation

PMA Number P200036

Class 3

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PMA 2026-09-09

Prosthesis, posterior spinal elements

Applicant Premia Spine, Ltd.

PMA Number P220002

Class 3

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PMA 2026-09-09

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

Applicant Life Technologies Corporation

PMA Number P240040

Class 3

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PMA 2026-09-09

Neurovascular Liquid Embolic Agent

Applicant Balt USA, LLC

PMA Number P250009

Class 3

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PMA 2026-09-08

Leadless pacemaker

Applicant Medtronic, Inc.

PMA Number P150033

Class 3

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PMA 2026-09-08

Hybrid stent graft, thoracic aortic lesion treatment

Applicant Vascutek, Ltd.

PMA Number P210006

Class 3

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