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 2016-11-21

replacement Heart-valve

Applicant Medtronic, Inc.

PMA Number P870078

Class 3

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PMA 2016-11-20

Implantable cardioverter defibrillator (non-CRT)

Applicant ABBOTT MEDICAL

PMA Number P950022

Class 3

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PMA 2016-11-18

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Applicant New Day Diagnostics, LLC

PMA Number P130001

Class 3

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PMA 2016-11-18

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Beckman Coulter, Inc.

PMA Number P980041

Class 3

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PMA 2016-11-17

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant ABBOTT MEDICAL

PMA Number P030054

Class 3

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PMA 2016-11-17

AID, SURGICAL, VISCOELASTIC

Applicant Alcon Laboratories

PMA Number P840064

Class 3

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PMA 2016-11-17

Intraocular pressure lowering implant

Applicant Alcon Research, Ltd.

PMA Number P150037

Class 3

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PMA 2016-11-17

Stimulator, invasive bone growth

Applicant Ahp Eos Buyer, Inc.

PMA Number P850035

Class 3

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PMA 2016-11-17

Cardiac ablation percutaneous catheter

Applicant Medtronic Cryocath, LP

PMA Number P020045

Class 3

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PMA 2016-11-17

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Applicant ABBOTT MEDICAL

PMA Number P030035

Class 3

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PMA 2016-11-17

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

Applicant Medtronic Cryocath, LP

PMA Number P100010

Class 3

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PMA 2016-11-17

Prosthesis, breast, inflatable, internal, saline

Applicant Bimini Health Tech

PMA Number P120011

Class 3

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