PMA P100047S120
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S120
- Product code
- DSQ
- Decision date
- 2018-11-15
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the implementation of a new profilometer with the capability to measure the leading-edge radius on the HVAD impeller.
Current openFDA PMA Record#
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S120
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-11-15
- Decision code
- APPR
- Date received
- 2018-05-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of a new profilometer with the capability to measure the leading-edge radius on the HVAD impeller.