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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.
 
DevicePIPELINE EMBOLIZATION DEVICES,PIPELINE FLEX EMBOLIZATION DEVICE
Generic NameIntracranial aneurysm flow diverter
ApplicantMicro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Supplement NumberS011
Date Received06/26/2014
Decision Date01/26/2015
Product Code OUT 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE DELIVERY SYSTEM OF THE PIPELINE¿ EMBOLIZATION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, PIPELINE¿ FLEX EMBOLIZATION DEVICE (PFED), AND REMAINS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (22 YEARS OF AGE OR OLDER) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS (IAS) IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS.
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