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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 NumberS003
Date Received06/23/1998
Decision Date07/10/1998
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 revision in the installation qualification (iq) and operational qualification (oq) validations for the strain relief equipment, as well as a revision int he preventative maintenance procedure for strain relief equipment to include monthly wire integrity verification.
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