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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 NameABSOLUTE PRO, ABSOLUTE PRO LL
Classification Namestent, iliac
ApplicantABBOTT VASCULAR INC.
PMA NumberP110028
Supplement NumberS003
Date Received05/24/2012
Decision Date06/21/2012
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Reduce the number of samples used from each lot during pyrogen testing.
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