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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.
 
DeviceREALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantObtech Medical GmbH
Landis And Gyr Strasse 1
Zug CH-6300
PMA NumberP070009
Supplement NumberS007
Date Received12/22/2009
Decision Date08/10/2010
Withdrawal Date03/17/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CONVERTING A MANUAL TO AN AUTOMATED PIN ORIENTING AND FEEDING ASSEMBLY PROCESS.
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