PMA P200046
- Device
- Harmony™ Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S013
- Product code
- NPV
- Decision date
- 2026-06-01
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- an increase in drying time during the sterilization of primary packaging components for the bioprostheses
Current openFDA PMA Record#
- Device
- Harmony™ Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S051
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2026-06-01
- Decision code
- OK30
- Date received
- 2026-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an increase in drying time during the sterilization of primary packaging components for the bioprostheses