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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.
 
Trade NameMYNX VASCULAR CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
ApplicantACCESS CLOSURE, INC.
PMA NumberP040044
Supplement NumberS001
Date Received04/06/2006
Decision Date05/16/2007
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 07M-0285
Notice Date 07/20/2007
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the mynx vascular closure system. The device is indicted for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5f, 6f, or 7f procedural sheath.
Approval Order Approval Order
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