PMA P950035S002

Device: NEUROCONTROL FREEHAND SYSTEM(R)
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S002
Product code: GZC
Decision date: 1998-07-28
Classification: Stimulator, Neuromuscular, Implanted
Generic name: Stimulator, neuromuscular, implanted
Approval order statement: Application submitted to inform the Agency of the potential for device malfunction induced by electrostatic discharge and the changes being implementing to address the effects of ESD on the device. The Special Supplement requested approval for revised manufacturing procedures, revised labeling for the clinician, and revised patient labeling.

Current openFDA PMA Record#

Device: NEUROCONTROL FREEHAND SYSTEM(R)
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S002
Product code: GZC
Generic name: Stimulator, neuromuscular, implanted
Decision date: 1998-07-28
Decision code: APPR
Date received: 1998-06-29
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Application submitted to inform the Agency of the potential for device malfunction induced by electrostatic discharge and the changes being implementing to address the effects of ESD on the device. The Special Supplement requested approval for revised manufacturing procedures, revised labeling for the clinician, and revised patient labeling.