PMA P990064
- Device
- Mosaic Neo Mitral Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S084
- Product code
- DYE
- Decision date
- 2026-03-03
- Generic name
- replacement Heart-valve
- Approval order statement
- approval for updates to the sewing cuff, suture markings, radiopaque marker, holder, and sizers.
Current openFDA PMA Record#
- Device
- Mosaic Neo Mitral Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S094
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2026-03-03
- Decision code
- APPR
- Date received
- 2025-09-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for updates to the sewing cuff, suture markings, radiopaque marker, holder, and sizers.