EXOGEN 4000+ BONE HEALING SYSTEM
FDA premarket approval P900009/S022 · decided 2006-06-26
Approval details
- PMA number
- P900009
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXOGEN 4000+ BONE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2005-12-16
- Decision date
- 2006-06-26
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- 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
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