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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.
 
DeviceLEGOO
Generic NameOccluder, internal vessel, temporary
ApplicantGENZYME CORP.
52 Binney Street
Cambridge, MA 02142
PMA NumberP110003
Date Received01/31/2011
Decision Date09/28/2011
Product Code OBC 
Docket Number 11M-0746
Notice Date 10/20/2011
Advisory Committee Cardiovascular
Clinical TrialsNCT00985634
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE LEGOO. THIS DEVICE IS INDICATED FOR TEMPORARY ENDOVASCULAR OCCLUSION OF BLOOD VESSELS BELOW THE NECK UP TO 4 MM IN DIAMETER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S004 S002 S003 
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