PMA P900009S022
- Device
- EXOGEN 4000+ BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S022
- Product code
- LPQ
- Decision date
- 2006-06-26
- Classification
- Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF THE EXISTING EXOGEN 2000+ AND EXOGEN 3000 LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEMS - SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) TO THE EXOGEN 4000+. THE EXOGEN 4000+ IS MODIFIED TO INCORPORATE USER-INTERFACE MODIFICATIONS AND DESIGN MODIFICATIONS TO COMPENSATE FOR CHANGES IN ELECTRONIC COMPONENT AVAILABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 4000+ BONE HEALING SYSTEM. THE EXOGEN 4000+ IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTABLISHED NON-UNIONS EXCLUDING SKULL AND VERTEBRA. IN ADDITION, IT IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FRACTURE, FOR FRESH, CLOSED, POSTERIORLY DISPLACED DISTAL RADIUS FRACTURES AND FRESH, CLOSED OR GRADE I OPEN TIBIAL DIAPHYSIS FRACTURES IN SKELETALLY MATURE INDIVIDUALS WHEN THESE FRACTURES ARE ORTHOPAEDICALLY MANAGED BY CLOSED REDUCTION AND CAST IMMOBILIZATION.
Current openFDA PMA Record#
- Device
- EXOGEN 4000+ BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S022
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2006-06-26
- Decision code
- APPR
- Date received
- 2005-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF THE EXISTING EXOGEN 2000+ AND EXOGEN 3000 LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEMS - SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) TO THE EXOGEN 4000+. THE EXOGEN 4000+ IS MODIFIED TO INCORPORATE USER-INTERFACE MODIFICATIONS AND DESIGN MODIFICATIONS TO COMPENSATE FOR CHANGES IN ELECTRONIC COMPONENT AVAILABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 4000+ BONE HEALING SYSTEM. THE EXOGEN 4000+ IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTABLISHED NON-UNIONS EXCLUDING SKULL AND VERTEBRA. IN ADDITION, IT IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FRACTURE, FOR FRESH, CLOSED, POSTERIORLY DISPLACED DISTAL RADIUS FRACTURES AND FRESH, CLOSED OR GRADE I OPEN TIBIAL DIAPHYSIS FRACTURES IN SKELETALLY MATURE INDIVIDUALS WHEN THESE FRACTURES ARE ORTHOPAEDICALLY MANAGED BY CLOSED REDUCTION AND CAST IMMOBILIZATION.