FDA PMA Approvals

replacement Heart-valve

Applicant Edwards Lifesciences, LLC

PMA Number P860057

Class 3

heart-valve, non-allograft tissue

Applicant Edwards Lifesciences, LLC

PMA Number P150036

Class 3

heart-valve, non-allograft tissue

Applicant Edwards Lifesciences, LLC

PMA Number P150048

Class 3

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant W. L. Gore and Associates, Inc.

PMA Number P200030

Class 3

Stent, carotid

Applicant Contego Medical, Inc.

PMA Number P240009

Class 3

Prosthesis, mitral valve, percutaneously delivered

Applicant Edwards Lifesciences, LLC

PMA Number P250019

Class 3

AID, SURGICAL, VISCOELASTIC

Applicant Johnson & Johnson Surgical Vision, Inc.

PMA Number P810031

Class 3

Agent, absorbable hemostatic, non-collagen based

Applicant ETHICON, Inc.

PMA Number N12159

Class 3

HEART-VALVE, MECHANICAL

Applicant Corcym S.r.l.

PMA Number P900060

Class 3

Multi-analyte test system with algorithmic analysis for detection of prostate cancer

Applicant Cleveland Diagnostics, Inc.

PMA Number P200048

Class 3

Unknown Device

Applicant Biomet Microfixation, Inc.

PMA Number P020016

Acid, hyaluronic, intraarticular

Applicant Ibsa Institut Biochimique SA

PMA Number P110005

Class 3