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 | S008 |
Date Received | 03/05/2012 |
Decision Date | 08/13/2012 |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the post-approval study protocol. |
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