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 | Spiral Valve System |
Classification Name | one-way air-leak valve |
Generic Name | one-way air-leak valve |
Applicant |
Gyrus ACMI, Inc. |
6675 185th avenue ne |
redmond, WA 98052 |
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HDE Number | H060002 |
Supplement Number | S011 |
Date Received | 05/08/2017 |
Decision Date | 06/07/2017 |
Product Code | |
Advisory Committee |
Anesthesiology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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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