PMA P060040S018
- Device
- THORATEC HEART MATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S018
- Product code
- DSQ
- Decision date
- 2012-06-22
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE SEALED OUTFLOW GRAFT BEND RELIEF COLLAR (SOBR COLLAR).
Current openFDA PMA Record#
- Device
- THORATEC HEART MATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S018
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2012-06-22
- Decision code
- APPR
- Date received
- 2012-04-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE SEALED OUTFLOW GRAFT BEND RELIEF COLLAR (SOBR COLLAR).