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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 CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC IRELAND
PMA NumberP030009
Supplement NumberS058
Date Received08/08/2011
Decision Date09/07/2011
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the maximum stent inner diameter (msid) for the medium vessel stent sizes (3. 0 mm to 4. 0 mm diameters) from 4. 75 mm to 5. 0 mm.
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