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 2023-10-27

Prosthesis, posterior spinal elements

Applicant Premia Spine, Ltd.

PMA Number P220002

Class 3

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PMA 2023-10-18

Iliac covered stent, arterial

Applicant Atrium Medical Corp.

PMA Number P120003

Class 3

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PMA 2023-10-12

Stent graft, infrapopliteal, venous arterialization

Applicant LimFlow, Inc.

PMA Number P220025

Class 3

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PMA 2023-09-29

Somatic gene mutation detection system

Applicant Entrogen, Inc.

PMA Number P220005

Class 3

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PMA 2023-09-26

Device, hemostasis, vascular

Applicant Terumo Medical Corporation

PMA Number P210017

Class 3

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PMA 2023-08-25

Drug coated prostatic dilation catheter for benign prostatic hyperplasia

Applicant Urotronic, Inc.

PMA Number P220029

Class 3

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PMA 2023-08-11

Lenses, soft contact, extended wear

Applicant Alcon Laboratories, Inc.

PMA Number P220007

Class 3

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PMA 2023-08-09

Stent graft, bypass, superficial femoral artery

Applicant Endologix, LLC

PMA Number P220021

Class 3

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PMA 2023-07-28

Device, thermal ablation, endometrial

Applicant Microcube, LLC

PMA Number P230002

Class 3

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PMA 2023-07-20

Stimulator, spinal-cord, totally implanted for pain relief

Applicant Biotronik Nro, Inc.

PMA Number P210037

Class 3

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PMA 2023-06-29

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P210002

Class 3

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PMA 2023-06-29

Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors

Applicant ARUP Laboratories

PMA Number P190033

Class 3

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