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 | ENTERRA INTESTINAL NEUROSTIMULATORS |
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 | S041 |
Date Received | 01/07/2010 |
Decision Date | 03/24/2010 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for reformulation of the hotmelt adhesive used in sterile barrier packaging: the device, as modified, will be marketed under the trade name enterra®therapy system and is indicated for treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic and idiopathic etiology. |
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