PMA P100047S176
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S176
- Product code
- DSQ
- Decision date
- 2021-03-30
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval of an update to an existing in process inspection procedure of the impeller at Medtronic.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S176
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-03-30
- Decision code
- APPR
- Date received
- 2021-03-01
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of an update to an existing in process inspection procedure of the impeller at Medtronic.