Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D
• Generic Name: Pulmonary valve prosthesis percutaneously delivered
• Applicant: Medtronic, Inc.; 8200 Coral Sea St. NE Mvs83; Mounds View, MN 55112
• PMA Number: P140017
• Supplement Number: S005
• Date Received: 09/01/2016
• Decision Date: 02/24/2017
• Product Code: NPV
• Docket Number: 17M-1227
• Notice Date: 03/10/2017
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00688571
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: Yes
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Melody Transcatheter Pulmonary Valve, Ensemble Transcatheter Valve Delivery System, and Ensemble II Transcatheter Valve Delivery System for expanding the indications to include patients with a dysfunctional surgical bioprosthetic pulmonary valve. The device is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valve that has >= moderate regurgitation and/or a mean RVOT gradient >= 35 mmHg.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling