PMA P060040S081
- Device
- HeartMate II Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S081
- Product code
- DSQ
- Decision date
- 2021-11-24
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Add an alternate sub-tier supplier for the PTFE felt material used to manufacture the apical cuff component.
Current openFDA PMA Record#
- Device
- HeartMate II Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S081
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-11-24
- Decision code
- OK30
- Date received
- 2021-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate sub-tier supplier for the PTFE felt material used to manufacture the apical cuff component.