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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLEGOO
Generic NameOccluder, internal vessel, temporary
ApplicantGenzyme Corp.
52 Binney St.
Cambridge, MA 02142
PMA NumberP110003
Supplement NumberS004
Date Received02/27/2014
Decision Date03/26/2014
Withdrawal Date05/21/2024
Product Code OBC 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENTATION OF A MODIFIED LEGOO FILLING AND INSPECTION PROCESS FOR THE 1.0 ML AND 2.5 ML LEGOO SYRINGES.
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