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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 NumberS008
Date Received01/10/2005
Decision Date06/02/2005
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 BOSTON SCIENTIFIC CORPORATION, WAYNE, NEW JERSEY TO CONDUCT PACKAGING AND LABELING OPERATIONS.
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