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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
DeviceMYNX VASCULAR CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ACCESS CLOSURE, INC.
5452 betsy ross drive
santa clara, CA 95054
PMA NumberP040044
Supplement NumberS010
Date Received11/13/2008
Decision Date01/08/2009
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for material and design changes to the advancer tube assembly.
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