PMA P100047S161
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S161
- Product code
- DSQ
- Decision date
- 2020-05-06
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Second source sub-tier supplier for the overlay component used on the HeartWare Left Ventricular Assist System controller.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S161
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-05-06
- Decision code
- OK30
- Date received
- 2020-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second source sub-tier supplier for the overlay component used on the HeartWare Left Ventricular Assist System controller.