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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 NumberS020
Date Received01/16/2002
Decision Date02/04/2002
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) the addition of test stimulation cables to the existing model 3057 test stimulation lead package and the model 3065u test stimulation lead kit, and 2) associated labeling revisions to the model 3065u interstim test stimulation lead kit technical manual and the interstim test stimulation components instructions for use.