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 |
Classification Name | replacement heart-valve |
Generic Name | replacement heart-valve |
Regulation Number | 870.3925 |
Applicant |
Medtronic, Inc. |
1851 e. deere ave. |
santa ana, CA 92705 |
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HDE Number | H020003 |
Supplement Number | S018 |
Date Received | 04/02/2013 |
Decision Date | 09/24/2013 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Installation of a new reverse osmosis, de-ionized water system. |
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