|
Device | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S003 |
Date Received | 10/18/1996 |
Decision Date | 04/17/1997 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDING AN ALTERNATE CONTRACT STERILIZER FACILITY, AND CHANGING THE MATERIAL AND CONFIGURATION OF THE STORAGE BOX FOR THE PUMPS AND CANNULAE |