OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS
FDA premarket approval P910066/S017 · decided 2003-08-01
Approval details
- PMA number
- P910066
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2002-12-20
- Decision date
- 2003-08-01
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR VARIOUS LABELING, SOFTWARE AND HARDWARE CHANGES.
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