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 2017-12-11

Cytomegalovirus (cmv) dna quantitative assay

Applicant Roche Molecular Systems, Inc.

PMA Number P160041

Class 2

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PMA 2017-12-08

heart-valve, non-allograft tissue

Applicant Edwards Lifesciences, LLC

PMA Number P150048

Class 3

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PMA 2017-12-08

Stimulator, electrical, implanted, for parkinsonian symptoms

Applicant Boston Scientific Corp

PMA Number P150031

Class 3

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PMA 2017-12-06

Coronary drug-eluting stent

Applicant Medtronic Vascular

PMA Number P160043

Class 3

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PMA 2017-11-30

Next generation sequencing oncology panel, somatic or germline variant detection system

Applicant Foundation Medicine, Inc.

PMA Number P170019

Class 3

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PMA 2017-11-30

Light source system, diagnostic endoscopic

Applicant KARL STORZ Endoscopy-America, Inc.

PMA Number P050027

Class 3

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PMA 2017-11-28

Coronary drug-eluting stent

Applicant Medinol, Ltd.

PMA Number P170008

Class 3

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PMA 2017-11-27

Stent, carotid

Applicant Medtronic Vascular, Inc.

PMA Number P060001

Class 3

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PMA 2017-11-27

STENT, ILIAC

Applicant Medtronic Vascular, Inc.

PMA Number P030045

Class 3

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PMA 2017-11-22

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number P780007

Class 3

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PMA 2017-11-22

Light adjustable lens (LAL) and light delivery device (LDD)

Applicant Rxsight, Inc.

PMA Number P160055

Class 3

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PMA 2017-11-16

Lenses, soft contact, extended wear

Applicant CooperVision, Inc.

PMA Number N17679

Class 3

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