PMA P950035S006

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S006
Product code: GZC
Decision date: 2000-07-05
Classification: Stimulator, Neuromuscular, Implanted
Generic name: Stimulator, neuromuscular, implanted
Approval order statement: APPROVAL FOR THE DISTRIBUTION OF AN INTRAMUSCULAR ELECTRODE AND INTRAMUSCULAR ELECTRODE INSERTION TOOL KIT AS COMPONENTS TO THE FREEHAND(TM) SYSTEM, AND LABELING CHANGES.

Current openFDA PMA Record#

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S006
Product code: GZC
Generic name: Stimulator, neuromuscular, implanted
Decision date: 2000-07-05
Decision code: APPR
Date received: 2000-02-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE DISTRIBUTION OF AN INTRAMUSCULAR ELECTRODE AND INTRAMUSCULAR ELECTRODE INSERTION TOOL KIT AS COMPONENTS TO THE FREEHAND(TM) SYSTEM, AND LABELING CHANGES.