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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 NumberS001
Date Received11/10/2003
Decision Date11/26/2003
Withdrawal Date12/27/2007
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFY THE METHOD OF CAPPING THE VIALS OF ENTERYX AND DMSO AND MODIFY THE OVERLAYING PROCESS.
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