SPINAL-STIM(R)
FDA premarket approval P850007/S014 · decided 1996-09-19
Approval details
- PMA number
- P850007
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPINAL-STIM(R)
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 1994-03-03
- Decision date
- 1996-09-19
- Days to decision
- 931 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- COMPANY PROVIDED FINAL DRAFT LABELING MODIFIED TO REFLECT THE LONG-TERM SUCCESS RATES FOR THE DEVICE. TRADE NAME:SPINAL-STIM
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