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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.
 
DeviceENTERYX PROCEDURE KIT
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameagent, bulking, injectable for gastro-urology use
Applicant
Boston Scientific Corp.
100 boston scientific way
mailstop: mb-16
marlborough, MA 01752
PMA NumberP020006
Supplement NumberS004
Date Received04/09/2004
Decision Date05/26/2004
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT LIFE SCIENCE OUTSOURCING, BREA, CALIFORNIA. FINAL ASSEMBLY OF THE ENTERYX INJECTOR AND THE KITTING PROCEDURES WILL BE PERFORMED AT THIS FACILITY.
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