PhysioStim, SpinalStim
FDA premarket approval P850007/S039 · decided 2018-08-22
Approval details
- PMA number
- P850007
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PhysioStim, SpinalStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2018-05-24
- Decision date
- 2018-08-22
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for the addition of two alternative external power supply units.
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