HEARTMATE VE LVAS
FDA premarket approval P920014 · decided 1994-09-30
Approval details
- PMA number
- P920014
- Trade name
- HEARTMATE VE LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 1992-03-30
- Decision date
- 1994-09-30
- Days to decision
- 914 days
- Decision code
- APWD
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE HEARTMATE (R) IP LVAS
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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 |