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 2026-05-15

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

Applicant Boston Scientific

PMA Number P960006

Class 3

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PMA 2026-05-15

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P930035

Class 3

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PMA 2026-05-15

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

Applicant Natera, Inc.

PMA Number P260004

Class 3

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PMA 2026-05-14

Device, hemostasis, vascular

Applicant Cordis US Corporation

PMA Number P040044

Class 3

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PMA 2026-05-13

Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation

Applicant TransMedics, Inc.

PMA Number P160013

Class 3

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PMA 2026-05-13

Stimulator, bone growth, non-invasive

Applicant Theragen, Inc.

PMA Number P190030

Class 3

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PMA 2026-05-13

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation

Applicant TransMedics, Inc.

PMA Number P200031

Class 3

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PMA 2026-05-13

Iliac covered stent, arterial

Applicant Atrium Medical Corp.

PMA Number P120003

Class 3

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PMA 2026-05-12

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant Medtronic Vascular

PMA Number P100021

Class 3

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PMA 2026-05-12

Prosthesis, breast, inflatable, internal, saline

Applicant Mentor Worldwide, LLC

PMA Number P990075

Class 3

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PMA 2026-05-11

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Abbott Laboratories

PMA Number P120008

Class 3

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PMA 2026-05-11

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P930036

Class 3

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