TCI HEARTMATE(R) 1000A IP LVAD
FDA premarket approval P920014/S001 · decided 1999-12-16
Approval details
- PMA number
- P920014
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TCI HEARTMATE(R) 1000A IP LVAD
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 1994-12-19
- Decision date
- 1999-12-16
- Days to decision
- 1823 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval to use Cardioflex(R) instead of Biomer for manufacturing the diaphragms for the device. The device is indicated for use as a bridge to transplantation in cardiac trnasplant candidates at risk of imminent death from nonreversible left ventricular failure.
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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 |