PMA P990064S095
- Device
- Mosaic Bioprosthesis, Models 305, 310
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S095
- Product code
- DYE
- Decision date
- 2025-10-23
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- modifications to the ethylene oxide sterilization cycle and additional sterilizers for the sub-tier supplier of sterile sutures used in valve assembly
Current openFDA PMA Record#
- Device
- Mosaic Bioprosthesis, Models 305, 310
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S095
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2025-10-23
- Decision code
- OK30
- Date received
- 2025-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modifications to the ethylene oxide sterilization cycle and additional sterilizers for the sub-tier supplier of sterile sutures used in valve assembly