PMA P100047S185
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S185
- Product code
- DSQ
- Decision date
- 2021-07-22
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Clarify/add inspection steps and to align procedures with the supplier for the motor header assembly used on the HVAD System pump.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S185
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-07-22
- Decision code
- OK30
- Date received
- 2021-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Clarify/add inspection steps and to align procedures with the supplier for the motor header assembly used on the HVAD System pump.