PMA P910066S017
- Device
- OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S017
- Product code
- LOF
- Decision date
- 2003-08-01
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- APPROVAL FOR VARIOUS LABELING, SOFTWARE AND HARDWARE CHANGES.
Current openFDA PMA Record#
- Device
- OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S017
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2003-08-01
- Decision code
- APPR
- Date received
- 2002-12-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR VARIOUS LABELING, SOFTWARE AND HARDWARE CHANGES.