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 2016-08-04

Transcatheter septal occluder

Applicant ABBOTT MEDICAL

PMA Number P040040

Class 3

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PMA 2016-08-02

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

Applicant Boston Scientific

PMA Number P960004

Class 3

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PMA 2016-08-02

Sealant, dural

Applicant Stryker Leibinger GmbH & Co KG

PMA Number P130014

Class 3

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PMA 2016-08-01

Device, hemostasis, vascular

Applicant Cardiva Medical, Inc.

PMA Number P120016

Class 3

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PMA 2016-08-01

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant Biotronik, Inc.

PMA Number P050023

Class 3

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PMA 2016-07-29

intraocular lens

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P880081

Class 3

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PMA 2016-07-27

LENS, INTRAOCULAR, TORIC OPTICS

Applicant Bausch & Lomb, Inc.

PMA Number P030002

Class 3

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PMA 2016-07-26

Cancer-related germline gene mutation detection system

Applicant Myriad Genetic Laboratories

PMA Number P140020

Class 3

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PMA 2016-07-25

Lens, contact (rigid gas permeable), extended wear

Applicant Bausch & Lomb

PMA Number P860022

Class 3

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PMA 2016-07-25

Lens, contact, orthokeratology, overnight

Applicant Bausch & Lomb

PMA Number P010062

Class 3

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PMA 2016-07-22

Implant, dermal, for aesthetic use

Applicant Q-Med AB

PMA Number P030050

Class 3

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PMA 2016-07-22

SYSTEM, TEST, HER-2/NEU, IHC

Applicant Agilent Technologies Singapore (International) Pte , Ltd.

PMA Number P980018

Class 3

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