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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.
 
DeviceANGELCHIK ANTI-REFLUX PROSTHESIS
Generic NameIMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
ApplicantAllergan, Inc.
5540 EKWILL STREET
SANTA BARBARA, CA 93111
PMA NumberP790006
Supplement NumberS005
Date Received06/21/1990
Decision Date10/25/1990
Withdrawal Date 05/07/2009
Product Code LEI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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