HEARTMATE XVE LVAS
FDA premarket approval P920014/S015 · decided 2001-05-31
Approval details
- PMA number
- P920014
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEARTMATE XVE LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Corp
- Date received
- 2001-02-23
- Decision date
- 2001-05-31
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL TO INCLUDE THE HEARTMATE. XVE LVAS UNDER P920014, WITH THE SAME INDICATIONS FOR USE AS FOR THE PREVIOUSLY APPROVED (IN SUPPLEMENT S7, APPROVAL LETTER DATED OCTOBER 6, 1998) VE LVAS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEARTMATE. XVE LVAS AND 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. SVE LVAS IS INDICATED FOR USE BOTH INSIDE AND OUTSI
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (K131179) | Thoratec Corp | 2013-07-18 |