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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.
 
DeviceASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP110011
Supplement NumberS013
Date Received08/17/2016
Decision Date02/01/2017
Withdrawal Date01/22/2020
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updated in-process sampling requirements and to remove redundant inspections.
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