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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceENTERYX PROCEDURE KIT
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantBoston Scientific Corp.
100 BOSTON SCIENTIFIC WAY
MAILSTOP: MB-16
MARLBOROUGH, MA 01752
PMA NumberP020006
Date Received02/11/2002
Decision Date04/22/2003
Withdrawal Date 12/27/2007
Product Code LNM 
Docket Number 04M-0145
Notice Date 04/01/2004
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ENTERYX PROCEDURE KIT. THE DEVICE IS INDICATED FOR ENDOSCOPIC INJECTION INTO THE REGION OF THE LOWER ESOPHAGEAL SPHINCTER (LES) FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS IN PATIENTS RESPONDING TO AND REQUIRING DAILY PHARMACOLOGICAL THERAPY WITH PROTON PUMP INHIBITORS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S004 S005 S008 
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