PMA P100047S125
- Device
- Heartware Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S125
- Product code
- DSQ
- Decision date
- 2018-07-11
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Implementation of an improved receiving process for the HVAD Controller 2.0 display.
Current openFDA PMA Record#
- Device
- Heartware Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S125
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-07-11
- Decision code
- OK30
- Date received
- 2018-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an improved receiving process for the HVAD Controller 2.0 display.