PMA P950035S008

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S008
Product code: GZC
Decision date: 2000-11-14
Classification: Stimulator, Neuromuscular, Implanted
Generic name: Stimulator, neuromuscular, implanted
Approval order statement: APPROVAL FOR 1) CHANGING THE MANUFACTURING SITE FOR THE FREEHAND IMPLANTABLE RECEIVER-STIMULATOR TO LEWICKI MICROELECTRONIC, GMBH; 2) ADDITION OF A RADIOGRAPHIC IDENTIFICATION LABEL TO THE IMPLANTABLE RECEIVER-STIMULATOR; AND 3) IMPLEMENTING SEVERAL DESIGN MODIFICATIONS INVOLVING THE ENCAPSULATING MATERIAL AND CIRCUITRY OF THE FREEHAND IMPLANTABLE RECEIVER-STIMULATOR.

Current openFDA PMA Record#

Device: NEUROCONTROL FREEHAND SYSTEM
Applicant: Biocontrol Technology, Inc.
PMA number: P950035
Supplement: S008
Product code: GZC
Generic name: Stimulator, neuromuscular, implanted
Decision date: 2000-11-14
Decision code: APPR
Date received: 2000-07-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) CHANGING THE MANUFACTURING SITE FOR THE FREEHAND IMPLANTABLE RECEIVER-STIMULATOR TO LEWICKI MICROELECTRONIC, GMBH; 2) ADDITION OF A RADIOGRAPHIC IDENTIFICATION LABEL TO THE IMPLANTABLE RECEIVER-STIMULATOR; AND 3) IMPLEMENTING SEVERAL DESIGN MODIFICATIONS INVOLVING THE ENCAPSULATING MATERIAL AND CIRCUITRY OF THE FREEHAND IMPLANTABLE RECEIVER-STIMULATOR.