|
Device | THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S041 |
Date Received | 02/23/2009 |
Decision Date | 04/24/2009 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE LABELING TO INCLUDE POST-APPROVAL STUDY INFORMATION FOR THE IVAD SYSTEM. |