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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 NameDRIVER AND MICRO-DRIVER CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC IRELAND
PMA NumberP030009
Supplement NumberS013
Date Received08/01/2007
Decision Date02/15/2008
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the software program used in the stent assembly welding process.
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