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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.
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
7000 central avenue, n.e.
minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS050
Date Received03/10/2008
Decision Date08/18/2008
Product Code
Advisory Committee Gastroenterology/Urology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the workstations used for welding battery header subassemblies.