PHYSIO-STIM BONE GROWTH STIMULATOR
FDA premarket approval P850007/S022 · decided 1998-08-13
Approval details
- PMA number
- P850007
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PHYSIO-STIM BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 1998-06-24
- Decision date
- 1998-08-13
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for a modification to the definition of non-union in the labeling (i.e., a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).
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