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 | S118 |
Date Received | 06/27/2016 |
Decision Date | 07/27/2016 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Update to the welding process parameters, welding electrode tip geometry, and accompanying documentation used in the manufacture of your medium rate battery assemblies for your restore, itrel, and synergy spinal cord stimulation (scs) systems; activa deep brain stimulation (dbs) therapy system; activa dystonia therapy system; reclaim dbs therapy for ocd system; interstim therapy system; enterra therapy system; and syncromed infusion system. |
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