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 |
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 | S227 |
Date Received | 08/11/2023 |
Decision Date | 10/20/2023 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing the mr unsafe labeling to mr conditional labeling for the enterra ii 37800 neurostimulator with two enterra therapy 4351 35 cm unipolar leads. |
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