THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
FDA premarket approval P920014/S023 · decided 2004-07-08
Approval details
- PMA number
- P920014
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 2004-01-09
- Decision date
- 2004-07-08
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR USE OF THE POWERSONIC SEALED LEAD ACID BATTERY (MODEL PS-1223) AS A REPLACEMENT FOR THE NO LONGER MANUFACTURED PANASONIC SEALED LEAD ACID BATTERY (MODEL LC-SA122R3EU) AS A SOURCE OF BATTERY POWER TO DRIVE THE HEARTMATE VE AND ZVE LEFT VENTRICULAR ASSIST SYSTEMS.
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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 |