Cervical-Stim
FDA premarket approval P030034/S009 · decided 2016-12-02
Approval details
- PMA number
- P030034
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cervical-Stim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2016-07-05
- Decision date
- 2016-12-02
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for a new fabric, modifications to the control unit housing, modifications to enlarge the Liquid Crystal Display (LCD), a change from a three-cell lithium-ion battery to a single lithium-ion battery, a change in the Printed Circuit Assembly (PCA), a modification to include a smaller power supply, updates to device firmware, a new iOS mobile application, and minor updates to labeling. The modified devices will be marketed under the trade names Spinal-Stim Model 5212 and Cervical-Stim Mod
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