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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 NumberS048
Date Received05/25/2023
Decision Date12/12/2023
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a product line extension, referred to as ReShape Lap-Band® 2.0 FLEX System, which contains the FLEX Tubing. The FLEX Tubing acts as a reservoir within the ReShape Lap-Band® 2.0 FLEX System and can expand to hold extra saline out of the band cuff, allowing the band stoma to temporarily dilate and facilitate the passage of a food bolus through the band
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