PMA P100047S122
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S122
- Product code
- DSQ
- Decision date
- 2018-08-13
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for changing the HVAD Battery configuration mode from "removable" to "non-removable".
Current openFDA PMA Record#
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S122
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-08-13
- Decision code
- APPR
- Date received
- 2018-05-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changing the HVAD Battery configuration mode from "removable" to "non-removable".