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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.
 
DeviceSPHINCTER 800 URINARY CONTROL SYSTEM
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP000053
Supplement NumberS005
Date Received01/04/2005
Decision Date10/13/2006
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF INHIBIZONE TREATMENT TO COMPONENTS OF THE SPHINCTER 800 URINARY CONTROL SYSTEM, SPECIFICALLY THE CUFFS, PUMPS, AND KINK RESISTANT TUBING.
Post-Approval StudyShow Report Schedule and Study Progress
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