HEARTMATE XVE LVAS
FDA premarket approval P920014/S031 · decided 2011-12-21
Approval details
- PMA number
- P920014
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEARTMATE XVE LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 2010-12-27
- Decision date
- 2011-12-21
- Days to decision
- 359 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT THORATEC CORPORATION IN SAN RAMON, CALIFORNIA FOR RECEIVING ACCEPTANCE ACTIVITIES, RECEIVING INSPECTION, WAREHOUSING, AND SHIPPING OPERATIONS.
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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 |