|
Device | TCI HEARTMATE 1000A IP LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S011 |
Date Received | 05/15/2000 |
Decision Date | 07/20/2000 |
Withdrawal Date
|
10/03/2014 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF THE PROTOCOL TO BE USED TO EXTEND THE SHELF LIFE FROM 2 YEARS TO 3 YEARS FOR PRODUCTS THAT ARE ETHYLENE OXIDE (EO) STERILIZED PER SPECIFICATION 24215 REV G IN THE FOLLOWING TYPES OF PACKAGING: BLISTER TRAY 0.040" PETG WITH TYVEK 1073B LID (COATED ONE SIDE WITH ADHESIVE) AND TYVEK POUCHES (INNER AND OUTER POUCHES) MADE WITH 1073B TYVEK, SEALED TO 48 GA PETG/2.0 MIL POLYETHYLENE. |