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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameANGELCHIK ANTI-REFLUX PROSTHESIS
Classification Nameimplant, anti-gastroesophageal reflux
Generic Nameanti gastroesophageal reflux implant
ApplicantBIOENTERICS CORP.
PMA NumberP790006
Supplement NumberS005
Date Received06/21/1990
Decision Date10/25/1990
Product Code
LEI[ Registered Establishments with LEI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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