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 2016-06-30

Device, hemostasis, vascular

Applicant Cordis US Corporation

PMA Number P100013

Class 3

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PMA 2016-06-28

Pulse-generator, single chamber, sensor driven, implantable

Applicant ABBOTT MEDICAL

PMA Number P970013

Class 3

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PMA 2016-06-28

System, laser, photodynamic therapy

Applicant Pinnacle Biologics, Inc.

PMA Number P990021

Class 3

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PMA 2016-06-27

intraocular lens

Applicant Bausch & Lomb

PMA Number P910061

Class 3

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PMA 2016-06-27

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Merz North America, Inc.

PMA Number P040047

Class 3

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PMA 2016-06-27

Lens, multifocal intraocular

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P080010

Class 3

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PMA 2016-06-27

Lens, multifocal intraocular

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P960028

Class 3

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PMA 2016-06-24

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Applicant Biotronik, Inc.

PMA Number P070008

Class 3

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PMA 2016-06-23

Implantable cardioverter defibrillator (non-CRT)

Applicant Boston Scientific

PMA Number P830060

Class 3

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PMA 2016-06-23

intraocular lens

Applicant Bausch & Lomb, Inc.

PMA Number P910056

Class 3

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PMA 2016-06-23

Lenses, soft contact, extended wear

Applicant Alcon Laboratories, Inc.

PMA Number P000030

Class 3

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PMA 2016-06-23

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Applicant Boston Scientific

PMA Number P950001

Class 3

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