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 2021-03-05

Assay, genotyping, hepatitis c virus

Applicant Abbott Molecular

PMA Number P120012

Class 2

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PMA 2021-02-24

System, laser, fiber optic, photodynamic therapy

Applicant Pinnacle Biologics, Inc.

PMA Number P940010

Class 3

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PMA 2020-10-28

Implant, hearing, active, middle ear, partially implanted

Applicant Ototronix, LLC

PMA Number P010023

Class 3

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PMA 2020-10-22

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

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P000014

Class 2

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PMA 2020-10-04

STENT, CORONARY

Applicant Poseidon Medical, Inc.

PMA Number P150039

Class 3

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PMA 2020-09-23

Assay, genotyping, hepatitis c virus

Applicant Fujirebio Europe N.V.

PMA Number P160016

Class 2

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PMA 2020-09-04

Artificial iris

Applicant Humanoptics AG

PMA Number P170039

Class 3

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PMA 2020-09-01

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number P850079

Class 3

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PMA 2020-08-07

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P010021

Class 2

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PMA 2020-08-07

Automated external defibrillators (non-wearable)

Applicant Cardinalhealth

PMA Number P190007

Class 3

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PMA 2020-07-21

Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

Applicant Gen-Probe

PMA Number P020011

Class 2

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PMA 2020-07-21

Prostrate cancer genes nucleic acid amplification test system

Applicant Gen-Probe Incorporated

PMA Number P100033

Class 3

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