PMA P060040S016
- Device
- HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S016
- Product code
- DSQ
- Decision date
- 2012-03-29
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR PROVIDING ADDITIONAL INFORMATION IN THE LABELING REGARDING PROPER ENGAGEMENT OF THE BEND RELIEF WITH THE SEALED OUTFLOW GRAFT OF THE DEVICE AT THE TIME OF IMPLANT.
Current openFDA PMA Record#
- Device
- HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S016
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2012-03-29
- Decision code
- APPR
- Date received
- 2012-02-28
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR PROVIDING ADDITIONAL INFORMATION IN THE LABELING REGARDING PROPER ENGAGEMENT OF THE BEND RELIEF WITH THE SEALED OUTFLOW GRAFT OF THE DEVICE AT THE TIME OF IMPLANT.