Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | NEUROCONTROL FREEHAND SYSTEM |
Generic Name | Stimulator, neuromuscular, implanted |
Regulation Number | 882.5860 |
Applicant | BIOCONTROL TECHNOLOGY, INC. 1945 EAST 97TH CLEVELAND, OH 44106-4720 |
PMA Number | P950035 |
Supplement Number | S004 |
Date Received | 04/07/1999 |
Decision Date | 05/18/1999 |
Product Code |
GZC |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 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. |
|
|