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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, MODEL M000572600
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 NumberS005
Date Received07/19/2004
Decision Date08/20/2004
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE PHYSICIAN AND PATIENT LABELING WHICH ENHANCES INFORMATION REGARDING ADVERSE EVENTS.
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