PMA P100047S140
- Device
- HeartWare Left Ventricular Assist Device System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S140
- Product code
- DSQ
- Decision date
- 2019-06-28
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Update to the leak tester software and firmware.
Current openFDA PMA Record#
- Device
- HeartWare Left Ventricular Assist Device System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S140
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-06-28
- Decision code
- OK30
- Date received
- 2019-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the leak tester software and firmware.