ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
FDA premarket approval P910066/S007 · decided 1998-04-03
Approval details
- PMA number
- P910066
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 1997-11-17
- Decision date
- 1998-04-03
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- Approval for a manufacturing site located at Orthologic Corp., 1275 W. Washington Street, Temple, AZ.
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