PMA P200046S044

Device: Harmony™ Transcatheter Pulmonary Valve
Applicant: Medtronic, Inc.
PMA number: P200046
Supplement: S044
Product code: NPV
Decision date: 2025-10-23
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: modifications to the ethylene oxide sterilization cycle and additional sterilizers for the sub-tier supplier of sterile sutures used in valve assembly

Current openFDA PMA Record#

Device: Harmony™ Transcatheter Pulmonary Valve
Applicant: Medtronic, Inc.
PMA number: P200046
Supplement: S044
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2025-10-23
Decision code: OK30
Date received: 2025-09-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modifications to the ethylene oxide sterilization cycle and additional sterilizers for the sub-tier supplier of sterile sutures used in valve assembly