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 2016-11-22

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Roche Diagnostics Operations, Inc.

PMA Number P130015

Class 2

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PMA 2016-11-22

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Roche Diagnostics Corp.

PMA Number P990012

Class 2

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PMA 2016-11-22

Absorbable collagen hemostatic agent with thrombin

Applicant Baxter Healthcare Corp

PMA Number P990009

Class 3

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PMA 2016-11-22

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

Applicant Biosense Webster, Inc.

PMA Number P030031

Class 3

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PMA 2016-11-22

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Applicant Roche Diagnostics Corp.

PMA Number P010054

Class 2

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PMA 2016-11-22

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

Applicant Roche Diagnostics Corp.

PMA Number P990056

Class 3

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PMA 2016-11-21

intraocular lens

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P990080

Class 3

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PMA 2016-11-21

replacement Heart-valve

Applicant Medtronic, Inc.

PMA Number P990064

Class 3

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PMA 2016-11-21

replacement Heart-valve

Applicant Medtronic, Inc.

PMA Number P980043

Class 3

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PMA 2016-11-21

heart-valve, non-allograft tissue

Applicant Medtronic, Inc.

PMA Number P970031

Class 3

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PMA 2016-11-21

heart-valve, non-allograft tissue

Applicant Medtronic Heart Valves

PMA Number P790007

Class 3

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PMA 2016-11-21

Excimer laser system

Applicant Alcon Laboratories, Inc.

PMA Number P020050

Class 3

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