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 STIMULATOR |
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 | S032 |
Date Received | 10/03/2008 |
Decision Date | 06/12/2009 |
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 the correction of two nuisance software anonalies in the transier patient information (tpi) application residing on the model 8870 softwrieapplication card. The device, as modified, will be. Marketed under the trade name enterra therapy system and is indicated for the treatment of chronic, intractable (drug refracltory) nausea and vomiting secondary to gastiroparesis of diabelic und idiopathic etiology. |
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