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Device | MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) |
Generic Name | Pulmonary valve prosthesis percutaneously delivered |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MVS83 MOUNDS VIEW, MN 55112 |
PMA Number | P140017 |
Supplement Number | S002 |
Date Received | 03/23/2016 |
Decision Date | 03/25/2016 |
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 |
Approval Order Statement Addition of a new laser welder in the manufacturing of the Melody Transcatheter Pulmonary Valve frame. |