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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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.
 
Trade NameSpiral Valve System
Classification Nameone-way air-leak valve
Generic Nameone-way air-leak valve
Applicant
Gyrus ACMI, Inc.
6675 185th avenue ne
redmond, WA 98052
HDE NumberH060002
Supplement NumberS011
Date Received05/08/2017
Decision Date06/07/2017
Product Code
OAZ[ Registered Establishments with OAZ ]
Advisory Committee Anesthesiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for adding the following information to device labeling for the hde: (a) addition of "valve fracture" to the spiration valve system instructions for use, (b) addition of "a piece of the valve could break off during removal" to spiration valve system patient information brochure, and, (c) reporting the occurrence of risks of valve breaks during the valve removal process ("2 out of 2,859 patients") to the spiration valve system patient information brochure.
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