PMA P980043S075
- Device
- Hancock II Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P980043
- Supplement
- S075
- Product code
- DYE
- Decision date
- 2020-12-16
- Generic name
- replacement Heart-valve
- Approval order statement
- Change in storage temperature requirements for the tissue fixation solution.
Current openFDA PMA Record#
- Device
- Hancock II Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P980043
- Supplement
- S075
- Product code
- DYE
- Generic name
- replacement Heart-valve
- 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.