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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, neuromuscular, implanted
Generic Namestimulator, neuromuscular, implanted
Regulation Number882.5860
1945 east 97th
cleveland, OH 44106-4720
PMA NumberP950035
Supplement NumberS004
Date Received04/07/1999
Decision Date05/18/1999
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following: 1) changing the manufacturing site for the epimysial probe, anode plate, and epimysial electrode to lewicki microelectronic, gmbh; 2) changing the site for packaging and sterilization of the freehand system electrode positioning kit and epimysial electrode to lewicki microelectronic , gmbh; 3) addition of two paper measuring tapes to the electrode positioning kit; 4) changing the materila used to support the anode plate and the coating over this material; 5) changing the material used to coat the weld of the epimysial electrode; 6) changing the vendor for the connector pin, strain relief springs, and center springs of the implantable connector of the epimysial electrode; 7) changing the manufacturing procedures, packaging, and sterlization process; and 8) changing the labeling to include symbols that conform to european ce marketing requirements.