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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.
 
Trade NameINTERSTIM SYSTEM FOR URINARY CONTROL
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS008
Date Received02/29/2000
Decision Date03/09/2000
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1)elimination of the or screening cable from the model 3080 and 3886 lead kits, 2) to use the generic term "fluoropolymer" in place of "ptfe," and 3) to make numerous minor revisions to the physician and hospital staff manual for the model 3012 quadripolar neurostimulator, models 3080 and 3886 leads, and model 3095 extension.
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