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 II IMPLANTABLE NEUROSTIMULATOR (INS) 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 | S087 |
Date Received | 05/08/2014 |
Decision Date | 07/16/2014 |
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 in accordance with 613(b) of the food and drug administrationsafety and innovation act (fdasia), a determination that your humanitarian use device (hud) meets the conditions of either subclause (i) or (ii) under section 520(m)(6)(a)(i) of the federal food, drug, and cosmetic act (fd&c act), as amended by the fdasia, so that your devicemay be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). The adn for this device has been determined tobe 4,000. |
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