PMA P060040S029

Device: THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S029
Product code: DSQ
Decision date: 2013-08-05
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: ADDITION OF THORATEC CORPORATION AS A SECONDARY SOURCE FOR THE ASSEMBLY OF THE 14V BATTERY CLIPS FOR THE THORATEC® HEARTMATE® II VENTRICULAR ASSIST SYSTEM (LVAS).

Current openFDA PMA Record#

Device: THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS)
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S029
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2013-08-05
Decision code: OK30
Date received: 2013-07-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF THORATEC CORPORATION AS A SECONDARY SOURCE FOR THE ASSEMBLY OF THE 14V BATTERY CLIPS FOR THE THORATEC® HEARTMATE® II VENTRICULAR ASSIST SYSTEM (LVAS).