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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePIPELINE EMBOLIZATION DEVICE
Generic NameIntracranial aneurysm flow diverter
ApplicantMicro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Date Received05/18/2010
Decision Date04/06/2011
Product Code OUT 
Docket Number 11M-0284
Notice Date 04/20/2011
Advisory Committee Neurology
Clinical TrialsNCT00777088
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE PIPELINE EMBOLIZATION DEVICE. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (AGE 22 AND ABOVE) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S004  S006 S007 S012 S001 S010 S013 S005 S011 S008 
S014 S015 S022 S023 S020 S028 S034 S035 S029 S030 S042 S017 
S016 S018 S019 S026 S027 S024 S021 S038 S037 S039 S031 S032 
S036 S033 S044 S040 S041 
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