PHYSIO-STIM BONE GROWTH STIMULATOR
FDA premarket approval P850007/S023 · decided 1998-08-14
Approval details
- PMA number
- P850007
- Supplement
- S023
- 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
- 1998-07-21
- Decision date
- 1998-08-14
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for the elimination of daily shut down after three hours ofuse and a change int he overall device lock-up time from 270 days to 365 days.
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