PMA P100047S150
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S150
- Product code
- DSQ
- Decision date
- 2020-01-27
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for implementation of a new machine for the manufacturing process of the HVAD Outflow Graft component.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S150
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-01-27
- Decision code
- APPR
- Date received
- 2019-11-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for implementation of a new machine for the manufacturing process of the HVAD Outflow Graft component.