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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.
 
DeviceBIOENTERICS LAP-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 NumberS002
Date Received01/24/2002
Decision Date08/01/2002
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE LAP-BAND ADUSTABLE GASTRIC BANDING (LAGB) SYSTEM: 1) INTRODUCTION OF A REDESIGNED ACCESS PORT (ACCESS PORT II); 2) REPLACE THE CALIBRATION TUBE (CALIBRATION TUBE I) CURRENTLY PROVIDED IN THE LAGB) SYSTEM WITH A REDESIGNED CALIBRATION TUBE (CALIBRATION TUBE II); AND 3) INTRODUCTION OF 2" ACCESS PORT NEEDLES TO BE SOLD AS AN ACCESSORY ITEM. IN ADDITION TO BEING SOLD AS COMPONENTS OF THE LAGB SYSTEM, BOTH THE ACCESS PORT II AND THE CALIBRATION TUBE II WILL BE SOLD AS SEPARATE ACCESSORIES.
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