CERVICAL-STIM
FDA premarket approval P030034/S004 · decided 2011-01-12
Approval details
- PMA number
- P030034
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERVICAL-STIM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2010-01-21
- Decision date
- 2011-01-12
- Days to decision
- 356 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN LEWISVILLE, TEXAS.
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