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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 VASCULAR SELF EXPANDING STENT SYSTEM
Classification Namestent, iliac
Generic Namestent, iliac
Applicant
ABBOTT VASCULAR INC.
3200 lakeside drive
santa clara, CA 92054
PMA NumberP110028
Supplement NumberS008
Date Received05/31/2013
Decision Date06/26/2013
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF A VENDOR OF THE STENT MARKER TABS.
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