PMA P990064S082
- Device
- Mosaic Bioprosthesis and Mosaic Ultra Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S082
- Product code
- DYE
- Decision date
- 2020-11-03
- Generic name
- replacement Heart-valve
- Approval order statement
- Approval for removal of the Leaflet Touching Bias inspection.
Current openFDA PMA Record#
- Device
- Mosaic Bioprosthesis and Mosaic Ultra Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S082
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2020-11-03
- Decision code
- APPR
- Date received
- 2020-04-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for removal of the Leaflet Touching Bias inspection.