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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
Classification Namedevice, incontinence, mechanical/hydraulic
Generic Namedevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
Applicant
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberP000053
Supplement NumberS046
Date Received09/25/2012
Decision Date11/13/2012
Product Code
EZY[ Registered Establishments with EZY ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MINOR DESIGN CHANGE TO THE PUMP SHELL INTERFACE TOLERANCES.
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