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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 CADENCE VASCULAR CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
ApplicantACCESS CLOSURE, INC.
PMA NumberP040044
Supplement NumberS037
Date Received03/10/2011
Decision Date04/05/2011
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a minor design change to modify the advancer tube to incorporate a dual slit design at the proximal end of the advancer tube. The device, as modified, will be marketed under the trade name mynx cadence vascular closure device and is indicated 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.
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