THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

FDA premarket approval P060040/S005 · decided 2010-01-20

Approval details

PMA number

P060040

Supplement

S005

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Generic name

Ventricular (assist) bypass

Applicant

ABBOTT MEDICAL

Date received

2009-04-20

Decision date

2010-01-20

Days to decision

275 days

Decision code

APPR

Product code

DSQ

Advisory committee

Cardiovascular

Expedited review

No

Location

Pleasanton, CA

Statement

APPROVAL FOR THE THORATEC HEARTMATE II LVAS. THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NON-REVERSIBLE LEFT VENTRICULAR FAILURE. IT IS NOW ALSO INDICATED FOR USE IN PATIENTS WITH NEW YORK HEART ASSOCIATION (NYHA) CLASS IIIB OR IV END-STAGE LEFT VENTRICULAR FAILURE WHO HAVE RECEIVED OPTIMAL MEDICAL THERAPY FOR AT LEAST 45 OF THE LAST 60 DAYS, AND ARE NOT CANDIDATES FOR CARDIAC TRANSPLANTATION. THE HEARTMATE II LVA

510(k) clearances by this applicant