PMA P100047S082
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S082
- Product code
- DSQ
- Decision date
- 2017-04-06
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for electrical, hardware, and software modifications to the controller, monitor, and AC/DC adapters.
Current openFDA PMA Record#
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S082
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-04-06
- Decision code
- APPR
- Date received
- 2016-08-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for electrical, hardware, and software modifications to the controller, monitor, and AC/DC adapters.