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 2016-12-02

Stimulator, bone growth, non-invasive

Applicant Orthofix, Inc.

PMA Number P850007

Class 3

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PMA 2016-12-02

Laparoscopic contraceptive tubal occlusion device

Applicant Femcare , Ltd.

PMA Number P920046

Class 3

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PMA 2016-12-02

Processor, cervical cytology slide, automated

Applicant Bd Diagnostic Systems

PMA Number P970018

Class 3

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PMA 2016-12-01

STENT, RENAL

Applicant Cordis US Corporation

PMA Number P890017

Class 3

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PMA 2016-12-01

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant ABBOTT MEDICAL

PMA Number P140009

Class 3

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PMA 2016-12-01

Agent, occluding, vascular, permanent

Applicant Medtronic Vascular, Inc.

PMA Number P140018

Class 3

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PMA 2016-12-01

Stimulator, spinal-cord, totally implanted for pain relief

Applicant ABBOTT MEDICAL

PMA Number P010032

Class 3

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PMA 2016-12-01

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Dako North America, Inc.

PMA Number P150027

Class 3

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PMA 2016-12-01

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Agilent Technologies, Inc.

PMA Number P150025

Class 3

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PMA 2016-12-01

Immunohistochemistry assay, antibody, programmed death-ligand 1

Applicant Agilent Technologies, Inc.

PMA Number P150013

Class 3

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PMA 2016-12-01

HEART-VALVE, MECHANICAL

Applicant Medtronic Ats Medical, Inc.

PMA Number P990046

Class 3

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PMA 2016-11-30

Prosthesis, spinous process spacer/plate

Applicant Companion Spine France

PMA Number P110008

Class 3

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