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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 NameGFX OVER-THE-WIRE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantARTERIAL VASCULAR ENGINEERING, INC.
PMA NumberP970035
Supplement NumberS010
Date Received10/21/1998
Decision Date11/17/1998
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 
The 30-day notice requested a change in the current secure strain relief process et temperature from 300 degrees f to 260 degrees f in order to optimize the process.
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