Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | 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 | S030 |
Date Received | 07/03/2019 |
Decision Date | 08/02/2019 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Proposing a process change which introduces an upgraded version of the Automated Calibration System (ACS) for the SpinaLogic, OL1000 Dual Coil, and OL1000 Single Coil (SC) (sizes 1, 2, 3, 4) Bone Growth Stimulator devices. |
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