PMA P950035S004

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S004
Product code: GZC
Decision date: 1999-05-18
Classification: Stimulator, Neuromuscular, Implanted
Generic name: Stimulator, neuromuscular, implanted
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.

Current openFDA PMA Record#

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S004
Product code: GZC
Generic name: Stimulator, neuromuscular, implanted
Decision date: 1999-05-18
Decision code: APPR
Date received: 1999-04-07
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.