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 2019-07-11

Lens, contact (rigid gas permeable), extended wear

Applicant CooperVision, Inc.

PMA Number P870024

Class 3

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PMA 2019-06-18

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Applicant Tosoh Bioscience, Inc.

PMA Number P910065

Class 3

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PMA 2019-06-03

Barrier, absorbable, adhesion

Applicant Baxter Healthcare Corp

PMA Number P050011

Class 3

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PMA 2019-05-24

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P190001

Class 3

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PMA 2019-05-24

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P190004

Class 3

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PMA 2019-05-16

Intracranial coil-assist stent

Applicant Stryker Neurovascular

PMA Number P180031

Class 3

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PMA 2019-05-07

Reherniation reduction device

Applicant Intrinsic Therapeutics

PMA Number P160050

Class 3

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PMA 2019-04-16

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant Baronova, Inc.

PMA Number P180024

Class 3

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PMA 2019-04-12

Somatic gene mutation detection system

Applicant QIAGEN GmbH

PMA Number P180043

Class 3

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PMA 2019-04-12

Excimer laser system

Applicant Amo Manufacturing USA, LLC

PMA Number P990010

Class 3

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PMA 2019-04-12

Excimer laser system

Applicant Amo Manufacturing USA, LLC

PMA Number P910062

Class 3

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PMA 2019-04-11

Scaffold, dissection repair

Applicant Philips Image Guided Therapy Corporation

PMA Number P180034

Class 3

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