EBI BONE HEALING SYSTEM(R)
FDA premarket approval P790002/S015 · decided 1998-03-12
Approval details
- PMA number
- P790002
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EBI BONE HEALING SYSTEM(R)
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1994-07-19
- Decision date
- 1998-03-12
- Days to decision
- 1332 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for the FLX(R)-S Coils (model numbers FLX 2-S, FLX 3-S, and FLX 4-S) which will be used to deliver the single repetitive pulse (SRP) signal produced by the EBI Bone Healing System(R) Model 1020-S control unit. The device, as modified, will be marketed under the trade name EBI FLX(R)-S Coils and used with the EBI Bone Healing System(R) Model 1020-S control unit which is indicated for the treatment of nonunions, failed fusions, and congenital pseudarthroses.
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