PMA P950035S005

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S005
Product code: GZC
Decision date: 2000-01-13
Classification: Stimulator, Neuromuscular, Implanted
Generic name: Stimulator, neuromuscular, implanted
Approval order statement: 1)Replace the MRI warning in the package insert,clinician manual and user manual with a precaution statement that provides information for performing MRI scanning of patients with the Freehand System; 2) modify the IDE card to include wording advising NeuroControl be contacted for information prior to MRI scanning; 3) "MRI Information Sheet" which provides guidance for MRI scanning will be provided upon request.

Current openFDA PMA Record#

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S005
Product code: GZC
Generic name: Stimulator, neuromuscular, implanted
Decision date: 2000-01-13
Decision code: APPR
Date received: 1999-11-24
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: 1)Replace the MRI warning in the package insert,clinician manual and user manual with a precaution statement that provides information for performing MRI scanning of patients with the Freehand System; 2) modify the IDE card to include wording advising NeuroControl be contacted for information prior to MRI scanning; 3) "MRI Information Sheet" which provides guidance for MRI scanning will be provided upon request.