|
Device | THORATEC VENTRICULAR ASSIST DEVICE SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S018 |
Date Received | 10/22/2001 |
Decision Date | 04/18/2002 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPGRADING THE EMBEDDED SOFTWARE (FIRMWARE) FOR THE TLC-II PORTABLE VAD DRIVER FROM VERSION 4.03 TO VERSION 4.11. |