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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 NumberS030
Date Received04/01/2010
Decision Date04/30/2010
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Moving post-sterile activities associated with product handling, storage and shipping from one facility to another facility on the same street.
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