PMA P100047S205
- Device
- HeartWare® Ventricular Assist System, HeartWare® System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S205
- Product code
- DSQ
- Decision date
- 2023-02-02
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Add an in-process quality inspection step to the manufacturing of the external battery charger.
Current openFDA PMA Record#
- Device
- HeartWare® Ventricular Assist System, HeartWare® System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S205
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2023-02-02
- Decision code
- OK30
- Date received
- 2023-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an in-process quality inspection step to the manufacturing of the external battery charger.