PMA P980043S085
- Device
- Hancock II Bioprosthesis, Models T505, T510
- Applicant
- Medtronic, Inc.
- PMA number
- P980043
- Supplement
- S085
- Product code
- DYE
- Decision date
- 2025-10-23
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- modifications to the ethylene oxide sterilization cycle and additional sterilizers for the sub-tier supplier of sterile sutures used in valve assembly
Current openFDA PMA Record#
- Device
- Hancock II Bioprosthesis, Models T505, T510
- Applicant
- Medtronic, Inc.
- PMA number
- P980043
- Supplement
- S085
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2025-10-23
- Decision code
- OK30
- Date received
- 2025-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modifications to the ethylene oxide sterilization cycle and additional sterilizers for the sub-tier supplier of sterile sutures used in valve assembly