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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 (LAGB) SYSTEM
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantMedtimo, Inc.
7625 Golden Triangle Dr.
Suite G
Eden Prairie, MN 55344
PMA NumberP000008
Supplement NumberS024
Date Received07/14/2011
Decision Date07/29/2011
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO MODIFY THE DIRECTIONS FOR USE FOR THE RAPIDPORT EZ PORT APPLIER, AN ACCESSORY TO THE LAP-BAND SYSTEM, TO CLARIFY THE PROPER METHOD OF HOLDING THE RAPIDPORT EZ PORT APPLIER AND HOW TO APPLY PRESSURE TO THE PORT APPLIER TO ENSURE THE CORRECT POSITIONING OF THE ACCESS PORT.
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