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 2016-09-21

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Applicant Biosense Webster, Inc.

PMA Number P010068

Class 3

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PMA 2016-09-21

Cardiac ablation percutaneous catheter

Applicant Biosense Webster, Inc.

PMA Number P950005

Class 3

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PMA 2016-09-21

Cardiac ablation percutaneous catheter

Applicant Biosense Webster, Inc.

PMA Number P040036

Class 3

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PMA 2016-09-20

Agent, injectable, embolic

Applicant Ev3 Neurovascular

PMA Number P030004

Class 3

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PMA 2016-09-19

Kit, rna detection, human papillomavirus

Applicant Gen-Probe Incorporated

PMA Number P100042

Class 3

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PMA 2016-09-19

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 2016-09-19

Kit, rna detection, human papillomavirus

Applicant Gen-Probe Incorporated

PMA Number P120007

Class 3

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PMA 2016-09-16

Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction

Applicant Medtronic Sofamor Danek USA, Inc.

PMA Number P000054

Class 3

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PMA 2016-09-16

Bone grafting material, dental, with biologic component

Applicant Medtronic, Inc.

PMA Number P050053

Class 3

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PMA 2016-09-14

STENT, ILIAC

Applicant Abbott Vascular-Cardiac Therapies

PMA Number P110043

Class 3

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PMA 2016-09-14

Acid, hyaluronic, intraarticular

Applicant Seikagaku Corp.

PMA Number P980044

Class 3

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PMA 2016-09-13

Femtosecond laser system for refractive correction

Applicant Carl Zeiss Meditec, Inc.

PMA Number P150040

Class 3

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