Physio-Stim
FDA premarket approval P850007/S037 · decided 2017-10-31
Approval details
- PMA number
- P850007
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Physio-Stim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2017-08-15
- Decision date
- 2017-10-31
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- approval for design modifications to garment, control unit housing, liquid crystal display (LCD), battery, printed circuit assembly, power supply, firmware, and mobile application to the Physio-Stim non-invasive bone growth stimulator devices. Labeling was updated to reflect design changes.
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