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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.
 
DeviceABSOLUTE PRO, ABSOLUTE PRO LL
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
ABBOTT VASCULAR INC.
3200 lakeside drive
santa clara, CA 92054
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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