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Trade Name | MELODY TRANSCATHETER PULMONARY VALVE |
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 | S026 |
Date Received | 04/10/2014 |
Decision Date | 05/07/2014 |
Product Code | |
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 bovine jugular vein tissue supplier. |