Premarket Approval (PMA)

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 Name: NEUROCONTROL FREEHAND SYSTEM
• Classification Name: stimulator, neuromuscular, implanted
• Generic Name: motor control neuroprosthesis
• Regulation Number: 882.5860
• Applicant: NEUROCONTROL CORP.
• PMA Number: P950035
• Supplement Number: S004
• Date Received: 04/07/1999
• Decision Date: 05/18/1999
• Product Code: GZC [ Registered Establishments with GZC ]
• Advisory Committee: Ear Nose & Throat
• Supplement Type: normal 180 day track
• Supplement Reason: location change: manufacturer
• 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.