PMA P870072S017

Device: THORATEC VENTRICULAR ASSIST DEVICE
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S017
Product code: DSQ
Decision date: 2002-10-09
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL TO EXPAND THE INDICATIONS FOR USE FOR THE TLC-II PORTABLE VAD DRIVER SYSTEM TO INCLUDE THE TRANSPORTATION OF VAD PATIENTS VIA GROUND AMBULANCE.

Current openFDA PMA Record#

Device: THORATEC VENTRICULAR ASSIST DEVICE
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S017
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2002-10-09
Decision code: APPR
Date received: 2001-08-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO EXPAND THE INDICATIONS FOR USE FOR THE TLC-II PORTABLE VAD DRIVER SYSTEM TO INCLUDE THE TRANSPORTATION OF VAD PATIENTS VIA GROUND AMBULANCE.