|
Device | THORATEC HEARTMATE STROKE VOLUME LIMITER |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S020 |
Date Received | 02/21/2003 |
Decision Date | 03/21/2003 |
Withdrawal Date
|
10/03/2014 |
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 |
Approval Order Statement APPROVAL FOR SPECIFIC ADDITIONAL SAFETY INSTRUCTIONS TO THE LABELING FOR THE STROKE VOLUME LIMITER. |