|
Device | Melody |
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 | S016 |
Date Received | 09/26/2019 |
Decision Date | 12/10/2019 |
Product Code |
NPV |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modification to the polypropylene resin material formulation used in the packaging lid and retainer assembly. |