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 2021-07-30

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

Applicant Pillar Biosciences

PMA Number P200011

Class 3

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PMA 2021-07-22

Shockwave intravascular lithotripsy system

Applicant Shockwave Medical, Inc.

PMA Number P200039

Class 3

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PMA 2021-07-14

Qualitative and Quantitative Hepatitis B Virus Antibody assays

Applicant Siemens Healthcare Diagnostics, Inc.

PMA Number P200017

Class 2

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PMA 2021-06-30

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy

Applicant Prostalund AB

PMA Number P010055

Class 3

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PMA 2021-04-28

Surgical cardiac ablation device, for treatment of atrial fibrillation

Applicant AtriCure, Inc.

PMA Number P200002

Class 3

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PMA 2021-04-22

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay

Applicant Ventana Medical Systems

PMA Number P200019

Class 3

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PMA 2021-04-02

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P890061

Class 3

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PMA 2021-04-02

Implantable pulse generator, pacemaker (non-CRT)

Applicant Boston Scientific

PMA Number P830026

Class 3

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PMA 2021-03-23

AID, SURGICAL, VISCOELASTIC

Applicant Bausch Health

PMA Number P200025

Class 3

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PMA 2021-02-02

Automated external defibrillators (non-wearable)

Applicant Aed Battery Exchange, LLC

PMA Number P190013

Class 3

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PMA 2021-01-11

Optoacoustic Imaging System

Applicant Seno Medical Instruments, Inc.

PMA Number P200003

Class 3

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PMA 2020-12-22

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant W. L. Gore and Associates, Inc.

PMA Number P200030

Class 3

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