PHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR
FDA premarket approval P850007/S026 · decided 2001-03-09
Approval details
- PMA number
- P850007
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- PHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2001-02-01
- Decision date
- 2001-03-09
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORTHOFIX, INC., MCKINNEY, TEXAS.
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