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 2016-09-06

Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Applicant Spectranetics Corp.

PMA Number P050018

Class 3

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PMA 2016-09-06

Pulse generator, permanent, implantable

Applicant Medtronic, Inc.

PMA Number P990001

Class 3

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PMA 2016-09-01

Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Applicant Microport Orthopedics, Inc.

PMA Number P030027

Class 3

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PMA 2016-08-30

STENT, RENAL

Applicant Boston Scientific Corp

PMA Number P060006

Class 3

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PMA 2016-08-29

Pump, infusion, implanted, programmable

Applicant Intera Oncology

PMA Number P800036

Class 3

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PMA 2016-08-26

Ablation system, high intensity focused ultrasound (HIFU), MR-guided

Applicant Insightec

PMA Number P110039

Class 3

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PMA 2016-08-26

Acid, hyaluronic, intraarticular

Applicant Fidia Farmaceutici S.P.A.

PMA Number P950027

Class 3

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PMA 2016-08-25

STENT, CORONARY

Applicant Medinol, Ltd.

PMA Number P110004

Class 3

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PMA 2016-08-25

TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS

Applicant Qiagen

PMA Number P010033

Class 3

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PMA 2016-08-24

System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Applicant Bard Peripheral Vascular, Inc.

PMA Number P130029

Class 3

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PMA 2016-08-23

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Applicant Revvity, Inc.

PMA Number P970037

Class 3

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PMA 2016-08-23

SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION

Applicant Cryolife, Inc.

PMA Number P970029

Class 3

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