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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.
Classification Namedevice, hemostasis, vascular
PMA NumberP040044
Supplement NumberS040
Date Received11/14/2011
Decision Date01/13/2012
Product Code
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for integrating the catheter delivery system of the mynx cadence device with the hydrogel sealant of the mynx with grip technology device. The device, as modified, will be marketed under the trade name mynxgrip 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 6f or 7f procedural sheath.