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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 NumberS033
Date Received11/18/2010
Decision Date12/16/2010
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE AMS 800 ARTIFICIAL URINARY SPHINCTER.
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