HEARTMATE LVAS SYSTEM
FDA premarket approval P920014/S025 · decided 2005-03-22
Approval details
- PMA number
- P920014
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEARTMATE LVAS SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 2004-12-27
- Decision date
- 2005-03-22
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT TRI-STATE HOSPITAL SUPPLY CORPORATION, YUMA, ARIZONA AND FOR A CHANGE IN THE CYTOTOXICITY TESTING PROCESS.
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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 |