PMA P100047S178
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- Product code
- DSQ
- Decision date
- 2021-06-28
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the update of the documentation of the Outflow Graft Design Specification.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S178
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-06-28
- Decision code
- APPR
- Date received
- 2021-04-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the update of the documentation of the Outflow Graft Design Specification.