PMA P990064S080
- Device
- Mosaic Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S080
- Product code
- DYE
- Decision date
- 2019-12-10
- Generic name
- replacement Heart-valve
- Approval order statement
- Approval for a modification to the polypropylene resin material formulation used in the packaging lid and retainer assembly.
Current openFDA PMA Record#
- Device
- Mosaic Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S080
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2019-12-10
- Decision code
- APPR
- Date received
- 2019-09-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the polypropylene resin material formulation used in the packaging lid and retainer assembly.