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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
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Mailstop: Mb-16
Marlborough, MA 01752
PMA NumberP020006
Supplement NumberS004
Date Received04/09/2004
Decision Date05/26/2004
Withdrawal Date12/27/2007
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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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