PMA P060040S086
- Device
- HeartMate II® Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S086
- Product code
- DSQ
- Decision date
- 2022-06-23
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for an alternate drop-in replacement battery cell within the Battery Stack sub-assembly.
Current openFDA PMA Record#
- Device
- HeartMate II® Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S086
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2022-06-23
- Decision code
- APPR
- Date received
- 2022-04-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate drop-in replacement battery cell within the Battery Stack sub-assembly.