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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABSOLUTE PRO, ABSOLUTE PRO LL
Generic NameSTENT, ILIAC
ApplicantABBOTT VASCULAR INC.
3200 LAKESIDE DRIVE
SANTA CLARA, CA 92054
PMA NumberP110028
Supplement NumberS003
Date Received05/24/2012
Decision Date06/21/2012
Product Code NIO 
Advisory Committee Cardiovascular
Clinical TrialsNCT00844532
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.
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