PMA P910066S024

Device: OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE
Applicant: Djo, LLC
PMA number: P910066
Supplement: S024
Product code: LOF
Decision date: 2007-12-10
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR THE MODIFICATION OF THE EXISTING COIL GEOMETRY, THE ADDITION OF A WIRED CONTROL BOX, THE RECONFIGURATION OF THE PATIENT PADDING SYSTEM, AND THE REMOVAL OF THE INFRARED PATIENT COMPLIANCE COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES.

Current openFDA PMA Record#

Device: OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE
Applicant: Djo, LLC
PMA number: P910066
Supplement: S024
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2007-12-10
Decision code: APPR
Date received: 2007-10-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODIFICATION OF THE EXISTING COIL GEOMETRY, THE ADDITION OF A WIRED CONTROL BOX, THE RECONFIGURATION OF THE PATIENT PADDING SYSTEM, AND THE REMOVAL OF THE INFRARED PATIENT COMPLIANCE COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES.