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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 NameINTEGRITY RX CORONARY STENT SYSTEM, INTEGRITY OTW CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
Applicant MEDTRONIC INC.
PMA NumberP030009
Supplement NumberS062
Date Received12/17/2012
Decision Date01/15/2013
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 
Addition of a leak tester and the removal of an acceptable quality limit test requirement.
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