|
Device | HEARTMATE LVAS SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S025 |
Date Received | 12/27/2004 |
Decision Date | 03/22/2005 |
Withdrawal Date
|
10/03/2014 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT TRI-STATE HOSPITAL SUPPLY CORPORATION, YUMA, ARIZONA AND FOR A CHANGE IN THE CYTOTOXICITY TESTING PROCESS. |