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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSNS URINARY EXTENSIONS, SNS URINARY LEADS
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue, n.e.
minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS158
Date Received09/09/2013
Decision Date10/03/2013
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 
Updates to the current final packlabel printing equipment controller, which is used during the sterile final package operation atmedtronic puerto rico operations company (mproc) in villalba, puerto rico.
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