OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATOR
FDA premarket approval P910066/S022 · decided 2006-10-13
Approval details
- PMA number
- P910066
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2006-08-31
- Decision date
- 2006-10-13
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN VISTA, CALIFORNIA.
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