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
• 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: S029
• Date Received: 02/08/2024
• Decision Date: 03/08/2024
• Product Code: NPV
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
implementation of test methods for additional microorganism detection and enumeration during pre-sterilization bioburden assessments