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 2016-03-03

ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG

Applicant Diasorin

PMA Number P970054

Class 3

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PMA 2016-02-29

Lenses, soft contact, extended wear

Applicant Unilens Corp., USA

PMA Number P890040

Class 3

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PMA 2016-02-25

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

Applicant Ceramtec GmbH

PMA Number P010001

Class 3

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PMA 2016-02-25

Acid, hyaluronic, intraarticular

Applicant Anika Therapeutics, Inc.

PMA Number P030019

Class 3

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PMA 2016-02-23

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Palette Life Sciences

PMA Number P000029

Class 3

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PMA 2016-02-18

Stimulator, bone growth, non-invasive

Applicant Djo, LLC

PMA Number P910066

Class 3

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PMA 2016-02-17

Sharps needle destruction device

Applicant Sharps Terminator, LLC

PMA Number P120018

Class 2

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PMA 2016-02-16

Coronary drug-eluting stent

Applicant Boston Scientific Corp

PMA Number P100023

Class 3

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PMA 2016-02-12

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant St. Jude Medical, Inc.

PMA Number P880006

Class 3

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PMA 2016-02-05

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Applicant Hologic, Inc.

PMA Number P920048

Class 3

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PMA 2016-02-04

Implanted fecal incontinence device

Applicant Boston Scientific Corp

PMA Number P010020

Class 3

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PMA 2016-02-04

Prosthesis, intervertebral disc

Applicant Centinel Spine, LLC

PMA Number P050010

Class 3

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