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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 TM II, MICRO STENT TM II XL, GFX TM, GFX TM XL
Classification Namestent, coronary
ApplicantARTERIAL VASCULAR ENGINEERING, INC.
PMA NumberP970035
Supplement NumberS002
Date Received01/29/1998
Decision Date02/23/1998
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change in location pilot
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at 3576 unocal place, bldg. B, santa rosa, ca and 7975 cameron drive (extrusion) windsor, ca.
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