PMA P200046S049
- Device
- Harmony™ Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S049
- Product code
- NPV
- Decision date
- 2026-02-10
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- changes to the layout, monitoring, and capacity of controlled environment areas
Current openFDA PMA Record#
- Device
- Harmony™ Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S049
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2026-02-10
- Decision code
- OK30
- Date received
- 2026-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the layout, monitoring, and capacity of controlled environment areas