- Device
- Harmony™ Transcatheter Pulmonic Valve System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S041
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-05-13
- Decision code
- OK30
- Date received
- 2025-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of process changes related to manufacturing steps of the inner tip and flange components of the Harmony Delivery Catheter System