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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameGARREN GASTRIC BUBBLE
Classification Nameimplant, intragastric for morbid obesity
Generic Nameintragastric implant for morbid obesity
ApplicantAMERICAN EDWARDS LABORATORIES
PMA NumberP840025
Supplement NumberS011
Date Received10/20/1986
Decision Date03/17/1987
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason other
Expedited Review Granted? No
Combination Product No
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