PMA P060040S038

Device: THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S038
Product code: DSQ
Decision date: 2015-02-12
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR IMPLEMENTATION OF AN ADDITIONAL EXISTING ELECTRICAL CONTINUITY TEST DURING THE MANUFACTURING PROCESS OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS).

Current openFDA PMA Record#

Device: THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S038
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2015-02-12
Decision code: APPR
Date received: 2015-01-13
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR IMPLEMENTATION OF AN ADDITIONAL EXISTING ELECTRICAL CONTINUITY TEST DURING THE MANUFACTURING PROCESS OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS).