PMA P100047S096
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S096
- Product code
- DSQ
- Decision date
- 2017-06-08
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Modify the inspection procedure for the impeller used in the HeartWare Ventricular Assist Device (HVAD) pump component.
Current openFDA PMA Record#
- Device
- HeartWare Left Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S096
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-06-08
- Decision code
- OK30
- Date received
- 2017-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the inspection procedure for the impeller used in the HeartWare Ventricular Assist Device (HVAD) pump component.