OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS
FDA premarket approval P910066/S016 · decided 2001-05-18
Approval details
- PMA number
- P910066
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2001-04-11
- Decision date
- 2001-05-18
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL TO: 1)REFORMAT THE PATIENT MANUALS FOR THE OL 1000 AND OL 1000 SC BONE GROWTH STIMULATORS PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING, 2) REFORMAT THE PATIENT MANUAL FOR THE SPINALOGIC(TM) BONE GROWTH STIMULATOR PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING.
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