PMA P100047S118
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S118
- Product code
- DSQ
- Decision date
- 2018-04-13
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the addition of 100% visual inspection of the HeartWare Ventricular Assist System Controller at final packaging.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S118
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-04-13
- Decision code
- APPR
- Date received
- 2018-03-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of 100% visual inspection of the HeartWare Ventricular Assist System Controller at final packaging.