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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
Predetermined Change Control Plan AuthorizedNo
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 S001 S004 S007 S006 S012 S015 S010 S013 S005 S011 
S008 S014 S017 S016 S024 S022 S023 S028 S029 S030 S037 S033 
S039 S036 S032 S051 S019 S018 S021 S020 S026 S027 S031 S034 
S035 S038 S048 S049 S050 S041 S044 S046 S052 S047 S042 S043 
S040 S053 S054 S055 
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