|
Device | OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | DJO, LLC 1430 DECISION STREET VISTA, CA 92081-8553 |
PMA Number | P910066 |
Supplement Number | S026 |
Date Received | 05/09/2012 |
Decision Date | 08/10/2012 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE AND ACCEPTANCE ACTIVITIES LOCATED IN VISTA, CALIFORNIA |