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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.
 
Trade NameLEGOO
Classification Nameoccluder, internal vessel, temporary
ApplicantGENZYME CORP.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 
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