HEARTMATE IP & VE LVAS
FDA premarket approval P920014/S009 · decided 1999-08-10
Approval details
- PMA number
- P920014
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEARTMATE IP & VE LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 1999-07-16
- Decision date
- 1999-08-10
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval to change the material of the retaining suture that TCI includes with each implant kit from Tevdek II 7-776 to #2 NOVAFIL(TM).
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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 |