EBI BONE HEALING SYSTEM-MODEL 1026
FDA premarket approval P790002/S021 · decided 1999-12-29
Approval details
- PMA number
- P790002
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EBI BONE HEALING SYSTEM-MODEL 1026
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1999-11-30
- Decision date
- 1999-12-29
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Seven modifications to the Model 1026. Addition of components to the printed wiring board, addition of a ferrite sleeve, change in the control unit and labeling changes.
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