PMA P980043S082
- Device
- Hancock II Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P980043
- Supplement
- S082
- Product code
- DYE
- Decision date
- 2025-04-16
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- an increase in maximum personnel occupancy in specific controlled environment areas
Current openFDA PMA Record#
- Device
- Hancock II Bioprosthesis
- Applicant
- Medtronic, Inc.
- PMA number
- P980043
- Supplement
- S082
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2025-04-16
- Decision code
- OK30
- Date received
- 2025-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an increase in maximum personnel occupancy in specific controlled environment areas