PMA P060040S006
- Device
- THORATEC HEARTMATE 2 LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S006
- Product code
- DSQ
- Decision date
- 2010-04-19
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE PUMP END BEND RELIEF (PEBR) REGION OF THE HEARTMATE II PERCUTANEOUS LEAD.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE 2 LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S006
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2010-04-19
- Decision code
- APPR
- Date received
- 2010-01-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE PUMP END BEND RELIEF (PEBR) REGION OF THE HEARTMATE II PERCUTANEOUS LEAD.