PMA P200046S047

Device: Harmony™ Transcatheter Pulmonic Valve System
Applicant: Medtronic, Inc.
PMA number: P200046
Supplement: S047
Product code: NPV
Decision date: 2026-01-16
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: to implement a process change to manufacturing steps related to the capsule attach components of the delivery catheter system and a new capsule attach backup mold

Current openFDA PMA Record#

Device: Harmony™ Transcatheter Pulmonic Valve System
Applicant: Medtronic, Inc.
PMA number: P200046
Supplement: S047
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-01-16
Decision code: OK30
Date received: 2026-01-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement a process change to manufacturing steps related to the capsule attach components of the delivery catheter system and a new capsule attach backup mold