TCI HEARTMATE IP LVAS
FDA premarket approval P920014/S008 · decided 1999-03-25
Approval details
- PMA number
- P920014
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TCI HEARTMATE IP LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 1999-03-17
- Decision date
- 1999-03-25
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval to modify section 9.6 of the current directions for use to include instructions for adding an additional retaining suture from the Outflow Graft Screw Ring to the Outflow Elbow Screw Ring to secure the outflow graft and outflow conduit.
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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 |