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 2019-10-23

Cancer-related germline gene mutation detection system

Applicant Myriad Genetic Laboratories, Inc.

PMA Number P190014

Class 3

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PMA 2019-10-23

Implantable pulse generator

Applicant Impulse Dynamics (Usa), Inc.

PMA Number P180036

Class 3

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PMA 2019-10-18

Assay, enzyme linked immunosorbent, hepatitis c virus

Applicant DiaSorin, Inc.

PMA Number P190011

Class 2

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PMA 2019-10-10

Lenses, soft contact, extended wear

Applicant Bausch & Lomb, Inc.

PMA Number P850068

Class 3

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PMA 2019-09-05

Analyzer, medical image

Applicant Carestream Dental, LLC

PMA Number P980025

Class 2

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PMA 2019-09-05

Prosthesis, intervertebral disc

Applicant Spinal Kinetics, LLC

PMA Number P170036

Class 3

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PMA 2019-08-21

heart-valve, non-allograft tissue

Applicant Medtronic, Inc.

PMA Number P060025

Class 3

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PMA 2019-08-19

Bone grafting material, dental, with biologic component

Applicant Lynch Biologics, LLC

PMA Number P040013

Class 3

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PMA 2019-08-16

Stimulator, carotid sinus nerve

Applicant Cvrx, Inc.

PMA Number P180050

Class 3

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PMA 2019-08-06

Device, hemostasis, vascular

Applicant Teleflex Medical, LLC

PMA Number P180025

Class 3

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PMA 2019-07-15

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Applicant Uroplasty, LLC

PMA Number P040050

Class 3

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PMA 2019-07-11

Lens, contact, orthokeratology, overnight

Applicant CooperVision, Inc.

PMA Number P050031

Class 3

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