PMA P140017

Device: Melody Transcatheter Pulmonary Valve
Applicant: Medtronic, Inc.
PMA number: P140017
Supplement: S023
Product code: NPV
Decision date: 2026-04-09
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: approval for an alternate sub-tier supplier of the resin used to manufacture the catheter shaft component of the Ensemble II Delivery System

Current openFDA PMA Record#

Device: Melody Transcatheter Pulmonary Valve
Applicant: Medtronic, Inc.
PMA number: P140017
Supplement: S034
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-04-09
Decision code: APPR
Date received: 2026-01-07
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an alternate sub-tier supplier of the resin used to manufacture the catheter shaft component of the Ensemble II Delivery System