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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 NameDISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC AVE, INC.
PMA NumberP970035
Supplement NumberS041
Date Received08/05/2002
Decision Date12/06/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the labeling for the medtronic ave s660, s670 & s7 with discrete technology over-the-wire coronary stent systems to reflect a minimum guide catheter inner diameter of 0. 056".
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