PMA P100047S190
- Device
- HeartWare® Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S190
- Product code
- DSQ
- Decision date
- 2021-10-18
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Change to the coating chemistry/process for the Vent Patch on the Controller and Battery Pack.
Current openFDA PMA Record#
- Device
- HeartWare® Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S190
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-10-18
- Decision code
- OK30
- Date received
- 2021-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the coating chemistry/process for the Vent Patch on the Controller and Battery Pack.