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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.
 
DeviceINTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
ms rcw225
minneapolis, MN 55432
PMA NumberP080025
Supplement NumberS067
Date Received03/28/2014
Decision Date04/24/2014
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
UPDATE THE SOFTWARE USED AT SEVERAL MEDTRONIC¿S MANUFACTURING FACILITIES.
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