PMA P060040S088
- Device
- HeartMate II Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S088
- Product code
- DSQ
- Decision date
- 2022-11-10
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Add an alternate supplier for the polyester mesh used in the manufacture of the HeartMate II Inflow Conduit subassembly.
Current openFDA PMA Record#
- Device
- HeartMate II Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S088
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2022-11-10
- Decision code
- OK30
- Date received
- 2022-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for the polyester mesh used in the manufacture of the HeartMate II Inflow Conduit subassembly.