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 | CONTEGRA PULMONARY VALVED CONDUIT |
Applicant |
Medtronic, Inc. |
1851 e. deere ave. |
santa ana, CA 92705 |
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HDE Number | H020003 |
Supplement Number | S001 |
Date Received | 12/04/2003 |
Decision Date | 02/18/2004 |
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 a shelf life extension from 2 years to 3 years. |
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