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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameoccluder, internal vessel, temporary
Generic Nameoccluder, internal vessel, temporary
500 kendall street
cambridge, MA 02142-1562
PMA NumberP110003
Date Received01/31/2011
Decision Date09/28/2011
Product Code
OBC[ Registered Establishments with OBC ]
Docket Number 11M-0746
Notice Date 10/20/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00985634
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004