PMA P100047S186
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S186
- Product code
- DSQ
- Decision date
- 2021-08-03
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Changes to the inspection process and manufacturing procedures related to spatter on the HVAD pump inflow tube.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S186
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-08-03
- Decision code
- OK30
- Date received
- 2021-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the inspection process and manufacturing procedures related to spatter on the HVAD pump inflow tube.