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 2023-06-23

Automated external defibrillators (non-wearable)

Applicant Graphic Controls D.B.A. Vermed

PMA Number P200007

Class 3

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PMA 2023-06-16

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Applicant Surmodics,Inc.

PMA Number P210025

Class 3

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PMA 2023-06-07

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

Applicant Tempus Labs, Inc.

PMA Number P210011

Class 3

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PMA 2023-05-19

Agent, absorbable hemostatic, non-collagen based

Applicant Baxter Healthcare Corporation

PMA Number P210036

Class 3

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PMA 2023-05-17

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

Applicant MicroPort CRM USA, Inc.

PMA Number P130010

Class 3

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PMA 2023-03-31

diaphragmatic/phrenic nerve laparoscopically-implanted stimulator

Applicant Synapse Biomedical, Inc.

PMA Number P200018

Class 3

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PMA 2023-02-22

AID, SURGICAL, VISCOELASTIC

Applicant Bausch Health Companies, Inc.

PMA Number P220009

Class 3

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PMA 2023-02-16

Excimer laser system

Applicant Carl Zeiss Meditec, Inc.

PMA Number P060004

Class 3

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PMA 2023-01-20

System, laser, photodynamic therapy

Applicant Bausch + Lomb Ireland Limited

PMA Number P050026

Class 3

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PMA 2023-01-11

Stimulator, electrical, implantable, for incontinence

Applicant Cirtec Medical Corporation

PMA Number P170001

Class 3

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PMA 2022-12-29

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Saluda Medical Pty, Ltd.

PMA Number P190002

Class 3

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PMA 2022-12-28

Nitric Oxide Generator and Delivery System

Applicant Beyond Air, Inc.

PMA Number P200044

Class 3

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