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 | 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 | S028 |
Date Received | 01/19/2016 |
Decision Date | 02/18/2016 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the labeling to be in conformance with IEC 60601-1-6 ED.3.1, IEC 60601-1-2, ANSI/AAMI ES 60601-1:2005/A1:2012 and IEC 60601-11:2011. |
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