PMA P200046S050
- Device
- Harmony™ Transcatheter Pulmonary Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S050
- Product code
- NPV
- Decision date
- 2026-03-24
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- to implement a process change for an alternative serial tag used in the manufacturing process of the implant
Current openFDA PMA Record#
- Device
- Harmony™ Transcatheter Pulmonary Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S050
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2026-03-24
- Decision code
- OK30
- Date received
- 2026-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a process change for an alternative serial tag used in the manufacturing process of the implant