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 2016-11-30

Implant, dermal, for aesthetic use

Applicant Q-Med AB

PMA Number P040024

Class 3

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PMA 2016-11-30

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Applicant Ventana Medical Systems, Inc.

PMA Number P100027

Class 3

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PMA 2016-11-30

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant Ortho-Clinical Diagnostics, Inc.

PMA Number P010021

Class 2

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PMA 2016-11-29

Implant, cochlear

Applicant Advanced Bionics

PMA Number P960058

Class 3

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PMA 2016-11-29

SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Applicant W. L. Gore & Associates, Inc.

PMA Number P040027

Class 3

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PMA 2016-11-28

Dorsal root ganglion stimulator for pain relief

Applicant ABBOTT MEDICAL

PMA Number P150004

Class 3

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PMA 2016-11-28

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

Applicant DePuy Orthopaedics, Inc.

PMA Number P070026

Class 3

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PMA 2016-11-22

Acid, hyaluronic, intraarticular

Applicant Fidia Farmaceutici

PMA Number P150010

Class 3

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PMA 2016-11-22

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Applicant Roche Diagnostics Corp.

PMA Number P000027

Class 3

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PMA 2016-11-22

Lenses, soft contact, extended wear

Applicant Vistakon, Johnson & Johnson Vision Products, Inc.

PMA Number N18033

Class 3

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PMA 2016-11-22

Absorbable coronary drug-eluting stent

Applicant Abbott Vascular, Inc.

PMA Number P150023

Class 3

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PMA 2016-11-22

Somatic gene mutation detection system

Applicant bioMerieux, Inc.

PMA Number P120014

Class 3

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