PMA P950035S001

Device: NEUROCONTROL FREEHAND SYSTEM(R)
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S001
Product code: GZC
Decision date: 1998-03-20
Generic name: Stimulator, neuromuscular, implanted
Approval order statement: Approval for a change in the supplier of the Platinum-Iridium (Pt-Ir) electrode discs used in the manufacture of the Freehand Epimysial Electrodes and a change in the Model Numbering for the Freehand System.

Current openFDA PMA Record#

Device: NEUROCONTROL FREEHAND SYSTEM(R)
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S001
Product code: GZC
Generic name: Stimulator, neuromuscular, implanted
Decision date: 1998-03-20
Decision code: APPR
Date received: 1998-02-10
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in the supplier of the Platinum-Iridium (Pt-Ir) electrode discs used in the manufacture of the Freehand Epimysial Electrodes and a change in the Model Numbering for the Freehand System.