TCI HEARTMATE 1000A IP LVAS
FDA premarket approval P920014/S011 · decided 2000-07-20
Approval details
- PMA number
- P920014
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- TCI HEARTMATE 1000A IP LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 2000-05-15
- Decision date
- 2000-07-20
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (K131179) | Thoratec Corp | 2013-07-18 |