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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.
 
DeviceGARREN GASTRIC BUBBLE
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantAmerican Edwards Laboratories
Clayton Professional Bldg.
Suite 3a 118 N. St.
Elkton, MD 21921
PMA NumberP840025
Supplement NumberS003
Date Received11/29/1985
Decision Date01/23/1986
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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