PMA P980043S074
- Device
- Hancock II Bioprosthesis
- Applicant
- Medtronic, Inc.
- Product code
- DYE
- Decision date
- 2021-01-05
- Generic name
- replacement Heart-valve
- Approval order statement
- Approval for continued use of a tissue supplier after a change in the suppliers name and facility address.
Current openFDA PMA Record#
- Device
- Hancock II Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P980043
- Supplement
- S074
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2021-01-05
- Decision code
- APPR
- Date received
- 2020-06-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for continued use of a tissue supplier after a change in the suppliers name and facility address.