|
Device | THORATEC 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 | S022 |
Date Received | 09/30/2002 |
Decision Date | 10/29/2002 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF INSPECTIONS, TEST METHODS, AND SPECIFICATIONS FOR THE CONTROLLER BOARDS FOR THE TLC-II PORTABLE VAD DRIVER. |