TCI HEARTMATE VE LVAS
FDA premarket approval P920014/S013 · decided 2000-10-20
Approval details
- PMA number
- P920014
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TCI HEARTMATE VE LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 2000-09-15
- Decision date
- 2000-10-20
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL TO MODIFY THE HEARTMATE VE SYSTEM CONTROLLER (C/N 1215) TO ACCOMODATE A NEW FOUR CELL BATTERY MODULE (BATTERY CELL), RESULTING IN VE SYSTEM CONTROLLER C/N 1216 AND BATTERY MODULE C/N 1264.
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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 |