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 2021-11-02

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Applicant Medtronic, Inc.

PMA Number P200028

Class 3

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PMA 2021-11-01

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Roche Diagnostics

PMA Number P190005

Class 2

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PMA 2021-10-15

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Spatz Fgia, Inc.

PMA Number P190012

Class 3

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PMA 2021-10-12

Immunohistochemistry assay, antibody, Ki-67

Applicant Agilent Technologies, Inc.

PMA Number P210026

Class 3

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PMA 2021-10-06

Automated breast ultrasound

Applicant Delphinus Medical Technologies

PMA Number P200040

Class 3

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PMA 2021-09-28

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation

Applicant TransMedics, Inc.

PMA Number P200031

Class 3

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PMA 2021-09-28

Gases used within eye to place pressure on detached retina

Applicant Airgas Therapeutics, LLC

PMA Number P900066

Class 3

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PMA 2021-09-26

Automated external defibrillators (non-wearable)

Applicant Conmed Corporation

PMA Number P200004

Class 3

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PMA 2021-09-03

Organ care system (OCS) heart system

Applicant TransMedics, Inc.

PMA Number P180051

Class 3

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PMA 2021-08-27

Stimulator, autonomic nerve, implanted for stroke rehabilitation

Applicant Mobia Medical, Inc.

PMA Number P210007

Class 3

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PMA 2021-08-19

Microspheres radionuclide

Applicant Boston Scientific Corporation

PMA Number P200029

Class 3

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PMA 2021-08-17

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay

Applicant Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

PMA Number P210001

Class 3

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