PMA P950035S010

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S010
Product code: GZC
Decision date: 2001-09-13
Classification: Stimulator, Neuromuscular, Implanted
Generic name: Stimulator, neuromuscular, implanted
Approval order statement: APPROVAL FOR REVISIONS TO THE LABELING THAT SPECIFY THE MAXIMUM DEPTH BELOW THE SURFACE OF THE SKIN AT WHICH THE IMPLANTABLE RECEIVER-STIMULATOR (IRS) SHOULD NOT EXCEED WHEN IMPLANTED AND CLARIFYING THE INSTRUCTIONS FOR CONNECTING THE EXTERNAL CONTROLLER TO THE CLINICAL PROGRAMMING STATION.

Current openFDA PMA Record#

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S010
Product code: GZC
Generic name: Stimulator, neuromuscular, implanted
Decision date: 2001-09-13
Decision code: APPR
Date received: 2001-08-14
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISIONS TO THE LABELING THAT SPECIFY THE MAXIMUM DEPTH BELOW THE SURFACE OF THE SKIN AT WHICH THE IMPLANTABLE RECEIVER-STIMULATOR (IRS) SHOULD NOT EXCEED WHEN IMPLANTED AND CLARIFYING THE INSTRUCTIONS FOR CONNECTING THE EXTERNAL CONTROLLER TO THE CLINICAL PROGRAMMING STATION.