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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameagent, bulking, injectable for gastro-urology use
Boston 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[ Registered Establishments with LNM ]
Docket Number 04M-0145
Notice Date 04/01/2004
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S004 S005 S008