PMA P060040S048

Device: THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS), THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S048
Product code: DSQ
Decision date: 2016-02-22
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for a change in the supplier facility location for the Emergency Backup Battery and Sealed Lead Acid Battery.

Current openFDA PMA Record#

Device: THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (LVAS), THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S048
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2016-02-22
Decision code: APPR
Date received: 2015-12-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in the supplier facility location for the Emergency Backup Battery and Sealed Lead Acid Battery.