HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM
FDA premarket approval P920014/S027 · decided 2007-06-29
Approval details
- PMA number
- P920014
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 2007-05-30
- Decision date
- 2007-06-29
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ALTERNATE SUPPLIER FOR THE POLYMER USED TO MANUFACTURE THE DIAPHRAGM USED IN THE DEVICE.
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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 |