PMA P920014S019
- Device
- HEARTMATE XVE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S019
- Product code
- DSQ
- Decision date
- 2004-06-29
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL OF THE POST APPROVAL STUDY FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- HEARTMATE XVE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S019
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2004-06-29
- Decision code
- APPR
- Date received
- 2003-02-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF THE POST APPROVAL STUDY FOR THE DEVICE.