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 | MEDTRONIC ENTERRA LEAD MODEL 4351 |
Classification Name | intestinal stimulator |
Generic Name | intestinal stimulator |
Applicant |
Enterra Medical, Inc. |
5353 wayzata blvd. |
suite 400 |
st. louis park, MN 55416 |
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HDE Number | H990014 |
Supplement Number | S010 |
Date Received | 08/22/2003 |
Decision Date | 11/18/2003 |
Product Code | |
Docket Number | 00M-1451 |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new manufacturing site located at medtronic puerto rico operations company (mprocj, medreal, road #31 km 24 hmn 4, ceiba norte industrialpark, juncos, puerto rico, 00777. |
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