PMA P060040S004
- Device
- THORATEC HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S004
- Product code
- DSQ
- Decision date
- 2009-12-04
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A NEW SEALED (GELWEAVE) OUTFLOW GRAFT WITH BEND RELIEF FOR USE WITH THE HEARTMATE II LVAS.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S004
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2009-12-04
- Decision code
- APPR
- Date received
- 2008-12-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW SEALED (GELWEAVE) OUTFLOW GRAFT WITH BEND RELIEF FOR USE WITH THE HEARTMATE II LVAS.