PMA P140017S035

Device: Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmonary Valve (Melody TPV) and th
Applicant: Medtronic, Inc.
PMA number: P140017
Supplement: S035
Product code: NPV
Decision date: 2026-06-09
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval for secondary packaging changes, including a new shipping temperature indicator, and minor labeling changes.

Current openFDA PMA Record#

Device: Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmonary Valve (Melody TPV) and th
Applicant: Medtronic, Inc.
PMA number: P140017
Supplement: S035
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-06-09
Decision code: APPR
Date received: 2026-03-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for secondary packaging changes, including a new shipping temperature indicator, and minor labeling changes.