EBI BONE HEALING SYSTEM(R)
FDA premarket approval P790002/S019 · decided 1998-07-27
Approval details
- PMA number
- P790002
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EBI BONE HEALING SYSTEM(R)
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1998-06-24
- Decision date
- 1998-07-27
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for revision of the indications and usage section of the labeling for Models 1200, 1020-S, 1026, and 101, to include the definition of nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
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