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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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 NumberS021
Date Received10/23/2009
Decision Date12/11/2009
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE CATHETER HUB BARREL AND COMPRESSION SPRING LOCATED INSIDE THE MYNX HANDLE.
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