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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 NumberS007
Date Received03/31/2008
Decision Date12/14/2008
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at nutek corporation of california, hayward, california, for e-beam sterilization.
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