PMA P970031S067
- Device
- Freestyle Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S067
- Product code
- LWR
- Decision date
- 2019-12-10
- Generic name
- heart-valve, non-allograft tissue
- 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
- Freestyle Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S067
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- 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.