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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.
 
DeviceLAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantMedtimo, Inc.
7625 Golden Triangle Dr.
Suite G
Eden Prairie, MN 55344
PMA NumberP000008
Supplement NumberS018
Date Received05/21/2010
Decision Date06/18/2010
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO MODIFY THE INSTRUCTIONS FOR USE TO ADD ¿DATA FROM A POST-APPROVAL STUDY SHOWED AN ESTIMATED EXPLANT RATE OF 6.5% PER YEAR OVER THE FIRST FIVE YEARS FOLLOWING IMPLANTATION¿ TO THE ADVERSE EVENTS SECTION.
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