PMA P060040S042

Device: THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S042
Product code: DSQ
Decision date: 2015-06-04
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: IMPLEMENTATION OF A SUPPLIERS FACILITY RELOCATION FOR CERTAIN COMPONENTS OF THE THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM AND THORATEC VENTRICULAR ASSIST DEVICE SYSTEM.

Current openFDA PMA Record#

Device: THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S042
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2015-06-04
Decision code: OK30
Date received: 2015-05-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF A SUPPLIERS FACILITY RELOCATION FOR CERTAIN COMPONENTS OF THE THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM AND THORATEC VENTRICULAR ASSIST DEVICE SYSTEM.