EBI BONE HEALING SYSTEM
FDA premarket approval P790002/S023 · decided 2005-09-26
Approval details
- PMA number
- P790002
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EBI BONE HEALING SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2005-06-17
- Decision date
- 2005-09-26
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR THREE NEW COILS: THE FLX 5, THE XL COILETTE AND THE MINI COILETTE AND A MODIFIED VERSION OF THE BONE HEALING SYSTEM MODEL 2001 CONTROLLER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI BONE HEALING SYSTEM AND IS INDICATED FOR THE TREATMENT OF FRACTURE NON-UNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDOARTHROSES IN THE APPENDICULAR SYSTEM.
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