PMA P910066S026
- Device
- OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S026
- Product code
- LOF
- Decision date
- 2012-08-10
- Classification
- Stimulator, Bone Growth, Non-invasive
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE AND ACCEPTANCE ACTIVITIES LOCATED IN VISTA, CALIFORNIA
Current openFDA PMA Record#
- Device
- OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S026
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2012-08-10
- Decision code
- APPR
- Date received
- 2012-05-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE AND ACCEPTANCE ACTIVITIES LOCATED IN VISTA, CALIFORNIA