- Device
- HeartMate II Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S078
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-10-27
- Decision code
- OK30
- Date received
- 2020-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternative second tier supplier of a component used to manufacture the Sealed Inflow Graft of the HeartMate II Left Ventricular Assist Device.