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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 NameMICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS
Classification Namestent, coronary
ApplicantARTERIAL VASCULAR ENGINEERING, INC.
PMA NumberP970035
Supplement NumberS005
Date Received09/18/1998
Decision Date09/30/1998
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Requested a change to utilize a circular "ring" light source to apply the uv light during the uv adhesive curing process. The requested change will provide constant 360 degree application of uv light to the uv adhesive and will no longer require rotation of the catheter assembly. This process change will eliminate the need for nitrogen cooling gas and will reduce the process time for the distal luer bond from 60 seconds to 38 seconds.
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