PMA P100047S075
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S075
- Product code
- DSQ
- Decision date
- 2016-06-23
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the manufacturing process updates for the HeartWare Left Ventricular Assist Device Controller.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S075
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-06-23
- Decision code
- APPR
- Date received
- 2016-05-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the manufacturing process updates for the HeartWare Left Ventricular Assist Device Controller.