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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 800 ARTIFICIAL URINARY SPHINCTER
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP000053
Supplement NumberS054
Date Received01/09/2015
Decision Date04/07/2015
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR MODIFICATION OF AMS 800 INHIBIZONE (IZ) LABELING TO MATCH THE AMS 700 IZ LABELING; MODIFY TERMS FOR CLARITY AND ACCURACY, AND MODIFY THE LABELINGTO CLARIFY THE UPPER QUANTITY OF IZ COATING ON THE DEVICE.
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