PMA P100047S191
- Device
- HeartWare® Ventricular Assist System or HeartWare® System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S191
- Product code
- DSQ
- Decision date
- 2021-11-23
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- New pull tester equipment.
Current openFDA PMA Record#
- Device
- HeartWare® Ventricular Assist System or HeartWare® System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S191
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-11-23
- Decision code
- OK30
- Date received
- 2021-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New pull tester equipment.