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Trade Name | MEDTRONIC MELODY TRANSCATHETER PULMONARY VALVE SYSTEM |
Classification Name | pulmonic valved conduit |
Generic Name | pulmonic valved conduit |
Applicant |
Medtronic, Inc |
8200 coral sea street ne mvs83 |
mounds view, MN 55112 |
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HDE Number | H080002 |
Supplement Number | S027 |
Date Received | 04/28/2014 |
Decision Date | 11/06/2014 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for various updates to the instructions for use of the device. |