EBI BONE HEALING SYSTEM
FDA premarket approval P790002/S020 · decided 1999-01-26
Approval details
- PMA number
- P790002
- Supplement
- S020
- 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
- 1998-12-22
- Decision date
- 1999-01-26
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for the EBI Bone Healing System - Model 2001, indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudoarthroses in the appendicular system.
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