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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 URINARY CONTROL SYSTEM
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 NumberS024
Date Received05/08/2009
Decision Date07/06/2009
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 Yes
Approval Order Statement 
APPROVAL OF A NEW, SMALLER 3.5 CM CUFF SIZE TO BE USED AS A COMPONENT OF THE EXISTING AMS 800 URINARY CONTROL SYSTEM, AND FOR RELATED LABELING CHANGES.
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