CervicalStim
FDA premarket approval P030034/S013 · decided 2018-12-20
Approval details
- PMA number
- P030034
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CervicalStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2018-09-27
- Decision date
- 2018-12-20
- Days to decision
- 84 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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