PMA P970031S069
- Device
- Freestyle Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S069
- Product code
- LWR
- Decision date
- 2020-12-16
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Change in storage temperature requirements for the tissue fixation solution.
Current openFDA PMA Record#
- Device
- Freestyle Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P970031
- Supplement
- S069
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in storage temperature requirements for the tissue fixation solution.