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 2024-09-04

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Beckman Coulter, Inc.

PMA Number P850048

Class 3

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PMA 2024-08-23

Barrier, absorbable, adhesion

Applicant Baxter Healthcare Corp

PMA Number P050011

Class 3

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PMA 2024-08-19

Prosthesis, intervertebral disc

Applicant Spinal Kinetics, LLC

PMA Number P170036

Class 3

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PMA 2024-08-14

Acute coronary syndrome event detector

Applicant Avertix Medical, Inc.

PMA Number P150009

Class 3

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PMA 2024-08-09

Prosthesis, intervertebral disc

Applicant Medtronic Sofamor Danek USA, Inc.

PMA Number P090029

Class 3

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PMA 2024-08-09

Excimer laser system

Applicant Amo Manufacturing USA, LLC

PMA Number P930016

Class 3

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PMA 2024-07-26

STENT, ILIAC

Applicant Medtronic Vascular, Inc.

PMA Number P030045

Class 3

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PMA 2024-07-01

Cardiac ablation percutaneous catheter

Applicant Medtronic, Inc.

PMA Number P930029

Class 3

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PMA 2024-07-01

CATHETER, PERCUTANEOUS (VALVULOPLASTY)

Applicant Toray Industries (America), Inc.

PMA Number P910054

Class 3

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PMA 2024-06-28

Acid, hyaluronic, intraarticular

Applicant Fidia Farmaceutici S.P.A.

PMA Number P950027

Class 3

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PMA 2024-06-28

Acid, hyaluronic, intraarticular

Applicant Fidia Farmaceutici S.P.A.

PMA Number P180040

Class 3

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PMA 2024-06-27

SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Applicant Boston Scientific Corp

PMA Number P930031

Class 3

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