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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 & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantARTERIAL VASCULAR ENGINEERING, INC.
PMA NumberP970035
Supplement NumberS006
Date Received09/21/1998
Decision Date04/27/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 5-year post-approval study protocol for the micro stent(r) ii and gfx(tm) over-the-wire coronary stent systems.
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