|
Device | TCI HEARTMATE(R) 1000A IP LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S004 |
Date Received | 12/26/1995 |
Decision Date | 03/13/1996 |
Withdrawal Date
|
10/03/2014 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day 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 REVISING THE LABELING TO DELETE THE HEMODYNAMIC CRITERIA FROM THE INDICATIONS FOR USE |