HEARTMATE(R) VE LVAS
FDA premarket approval P920014/S007 · decided 1998-09-29
Approval details
- PMA number
- P920014
- Supplement
- S007
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEARTMATE(R) VE LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 1997-07-02
- Decision date
- 1998-09-29
- Days to decision
- 454 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- approval for the HeartMate(R) VE LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The HeartMate(R) VE LVAS is indicated for use both inside and outside the hospital.
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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 |