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 THERAPY SYSTEM |
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 | S020 |
Date Received | 03/13/2006 |
Decision Date | 05/22/2006 |
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 a change in the algorithm used to estimate battery longevity and the addition of the transfer patient information (tpi) feature to the model 8870 n'vision software application card. The enterra t'therapy system is indicated for the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic and idiopathic etiology. |
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