ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
FDA premarket approval P910066/S002 · decided 1997-01-03
Approval details
- PMA number
- P910066
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 1996-02-20
- Decision date
- 1997-01-03
- Days to decision
- 318 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR A LABELING CHANGE FOR THE DEVICE TO REFERENCE THE RESULTS OF AN EXPANDED PATIENT DATA REGISTRY FOR PATIENTS TREATED WITH THE DEVICE DURING THE FIRST TWO YEARS OF MARKETING FOR THE APPROVED INDICATION.
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