PMA P200046S042
- Device
- Harmony Transcatheter Pulmonary Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S042
- Product code
- NPV
- Decision date
- 2025-06-12
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- removal of an IPA washing step for the Endurant, Harmony, and Valiant stent rings and coils
Current openFDA PMA Record#
- Device
- Harmony Transcatheter Pulmonary Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S042
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-06-12
- Decision code
- OK30
- Date received
- 2025-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of an IPA washing step for the Endurant, Harmony, and Valiant stent rings and coils