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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 NumberS008
Date Received08/08/1986
Decision Date10/16/1986
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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