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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 2 OVER-THE-WIRE CORONARY STSENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantARTERIAL VASCULAR ENGINEERING, INC.
PMA NumberP970035
Supplement NumberS016
Date Received04/26/1999
Decision Date05/14/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested that gfx(r) ring components annealed at 985 degrees celsius for 20 minutes be utilized for the manufacturing of the gfx2 stent component. The change is being requested in order to utilize the existing inventory of gfx ring components for the manufacture of gfx2 stent.
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