PMA P950035S009

Device: NEUROCONTROL FREEHAND II SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S009
Product code: GZC
Decision date: 2002-01-18
Classification: Stimulator, Neuromuscular, Implanted
Generic name: Stimulator, neuromuscular, implanted
Approval order statement: APPROVAL FOR THE UNIVERSAL EXTERNAL CONTROLLER (UEC), REVISED FREEHAND CLINICIAN PROGRAMMING INTERFACE SOFTWARE, VERSION 5.0, WHICH ARE USED TO OPERATE AND PROGRAM THE FREEHAND IMPLANTABLE-RECEIVER STIMULATOR, AND SUBSEQUENT CHANGES TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FREEHAND II SYSTEM.

Current openFDA PMA Record#

Device: NEUROCONTROL FREEHAND II SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S009
Product code: GZC
Generic name: Stimulator, neuromuscular, implanted
Decision date: 2002-01-18
Decision code: APPR
Date received: 2000-12-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE UNIVERSAL EXTERNAL CONTROLLER (UEC), REVISED FREEHAND CLINICIAN PROGRAMMING INTERFACE SOFTWARE, VERSION 5.0, WHICH ARE USED TO OPERATE AND PROGRAM THE FREEHAND IMPLANTABLE-RECEIVER STIMULATOR, AND SUBSEQUENT CHANGES TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FREEHAND II SYSTEM.