PMA P870072

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S062
Product code: DSQ
Decision date: 2016-06-14
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Implementation of a new facility (same supplier) to provide the Battery Pack Assembly TLC II for the Thoratec Ventricular Assist Device (VAD).

Current openFDA PMA Record#

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S062
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2016-06-14
Decision code: OK30
Date received: 2016-05-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new facility (same supplier) to provide the Battery Pack Assembly TLC II for the Thoratec Ventricular Assist Device (VAD).