PMA P060040S028
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S028
- Product code
- DSQ
- Decision date
- 2013-09-25
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE UNIVERSAL BATTERY CHARGER.
Current openFDA PMA Record#
- Device
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S028
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-09-25
- Decision code
- APPR
- Date received
- 2013-07-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE UNIVERSAL BATTERY CHARGER.