PMA P060040S008
- Device
- THORATEC HEARTMATE2 LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S008
- Product code
- DSQ
- Decision date
- 2010-09-30
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A SEALED INFLOW CONDUIT.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE2 LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S008
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2010-09-30
- Decision code
- APPR
- Date received
- 2010-04-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A SEALED INFLOW CONDUIT.