PMA P990064S088
- Device
- Mosaic Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S088
- Product code
- DYE
- Decision date
- 2024-04-22
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- a raw material supplier change for sutures used in the valve assembly
Current openFDA PMA Record#
- Device
- Mosaic Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S088
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2024-04-22
- Decision code
- OK30
- Date received
- 2024-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a raw material supplier change for sutures used in the valve assembly