PMA P990064S089
- Device
- Mosaic™ Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S089
- Product code
- DYE
- Decision date
- 2025-01-22
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- approval for a change in detergent used in the washing process of cloth-covered stent subassemblies.
Current openFDA PMA Record#
- Device
- Mosaic™ Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S089
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2025-01-22
- Decision code
- APPR
- Date received
- 2024-06-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change in detergent used in the washing process of cloth-covered stent subassemblies.