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 2018-08-10

Intraocular pressure lowering implant

Applicant Alcon Research, LLC

PMA Number P170034

Class 3

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PMA 2018-08-09

Implantable pulse generator, pacemaker (non-CRT)

Applicant Biotronik, Inc.

PMA Number P820076

Class 3

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PMA 2018-07-26

Sealant, polymerizing

Applicant Baxter Bio Science

PMA Number P030039

Class 3

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PMA 2018-07-26

Drug eluting permanent left ventricular (lv) pacemaker electrode

Applicant Guidant Corp.

PMA Number P050046

Class 3

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PMA 2018-07-20

Somatic gene mutation detection system

Applicant Abbott Molecular, Inc.

PMA Number P170041

Class 3

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PMA 2018-07-11

Device, thermal ablation, endometrial

Applicant CooperSurgical, Inc.

PMA Number P000032

Class 3

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PMA 2018-06-21

Intraocular pressure lowering implant

Applicant Glaukos Corporation

PMA Number P170043

Class 3

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PMA 2018-05-30

Artificial iris

Applicant Humanoptics AG

PMA Number P170039

Class 3

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PMA 2018-05-18

System, laser, fiber optic, photodynamic therapy

Applicant Pinnacle Biologics, Inc.

PMA Number P940010

Class 3

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PMA 2018-05-08

Acid, hyaluronic, intraarticular

Applicant Mesoblast

PMA Number P170016

Class 3

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PMA 2018-04-30

Lenses, soft contact, extended wear

Applicant Bausch and Lomb, Inc.,

PMA Number P170035

Class 3

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PMA 2018-04-23

AID, SURGICAL, VISCOELASTIC

Applicant Altacor , Ltd.

PMA Number P960011

Class 3

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