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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.
 
DeviceAMS SPHINCTER 800 URINARY PROSTHESIS
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP000053
Supplement NumberS004
Date Received03/11/2004
Decision Date05/07/2004
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING PROCEDURE TO PRODUCE THE CUFF BACKING, A DESIGN CHANGE TO THE THICKNESS OF THE CUFF BACKING, A MATERIAL CHANGE IN THE SILICONE, AND A PROMOTIONAL CLAIM REGARDING THE CUFF WEAR CHARACTERISTICS OF THE MODIFIED DESIGN.
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