Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
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Trade Name | MELODY TRANSCATHETER PULMONARY VALVE |
Applicant |
Medtronic, Inc |
8200 coral sea street ne mvs83 |
mounds view, MN 55112 |
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HDE Number | H080002 |
Supplement Number | S009 |
Date Received | 07/11/2012 |
Decision Date | 08/27/2012 |
Notice Date | 08/23/2012 |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the reporting due date to be moved from january 24 to july 26 to aid fda our preparations for the annual pediatric advisory committee (pac) meeting. |
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