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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
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 NumberS037
Date Received06/09/2011
Decision Date06/24/2011
Product Code
EZY[ Registered Establishments with EZY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS 800 CONTROL PUMP, A COMPONENT OF THE AMS SPHINCTER 800 URINARY PROSTHESIS.
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