|
Device | TLC-II PLUS PORTABLE VAD DRIVER |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S042 |
Date Received | 09/04/2009 |
Decision Date | 11/05/2009 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR INCREASING THE SERVICE INTERVAL FOR THE TLC-IIPLUS PORTABLE VAD DRIVER FROM 3000 HOURS TO 4500 HOURS. |