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 2024-02-29

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Spatz Fgia, Inc.

PMA Number P190012

Class 3

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PMA 2024-01-26

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Applicant Ventana Medical Systems, Inc.

PMA Number P100027

Class 3

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PMA 2024-01-09

Sensor, glucose, invasive

Applicant Dexcom, Inc.

PMA Number P120005

Class 3

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PMA 2024-01-09

Automated external defibrillators (non-wearable)

Applicant Tz Medical, Inc.

PMA Number P200005

Class 3

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PMA 2023-12-12

Cardiac ablation percutaneous catheter

Applicant Boston Scientific Corp

PMA Number P980003

Class 3

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PMA 2023-12-12

STENT, RENAL

Applicant Boston Scientific Corp

PMA Number P060006

Class 3

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PMA 2023-12-07

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Palette Life Sciences

PMA Number P100014

Class 3

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PMA 2023-11-07

HEART-VALVE, MECHANICAL

Applicant Medtronic Ats Medical, Inc.

PMA Number P990046

Class 3

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PMA 2023-10-26

Stimulator, bone growth, non-invasive

Applicant Ahp Eos Buyer, Inc.

PMA Number P790002

Class 3

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PMA 2023-10-25

intraocular lens

Applicant Hoya Surgical Optics, Inc.

PMA Number P080004

Class 3

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PMA 2023-10-19

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant Qiagen Gaithersburg, Inc.

PMA Number P890064

Class 3

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PMA 2023-10-12

Cross-sectional mammographic xray system

Applicant Koning Corporation

PMA Number P130025

Class 3

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