|
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 | S024 |
Date Received | 12/11/2002 |
Decision Date | 12/31/2002 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF A WARNING STATEMENT TO THE PACKAGE LABELS AND TO THE INSTRUCTIONS FOR USE FOR THE BEVELED-TIP ATRIAL CANNULA, AS USED WITH THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM. |