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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceOL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
DJO, LLC
1430 decision street
vista, CA 92081-8553
PMA NumberP910066
Supplement NumberS019
Date Received01/20/2004
Decision Date09/10/2004
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR 1) CHANGE IN THE LABELING TO REFLECT THE NEW COMPANY OWNERSHIP FROM ORTHOLOGIC TO DJ ORTHOPEDICS/ REGENTEK; 2) ADDITION OF A PRODUCT SPECIFICATIONS SECTION TO ALL MANUALS TO COMPLY WITH CANADIAN STANDARDS ASSOCIATION. (APPLIES TO OL SERIES AND SPINALOGIC MANUALS); 3) ADDITION OF REFERENCE SECTION (APPLIES TO SPINALOGIC MANUALS ONLY); AND 4) IN RISK AND BENEFITS SECTION OF THE SPINALOGIC PATIENT MANUAL, REVISION THE STATEMENT "20% GREATER CHANCE OF BACK SURGERY HEALING" TO "THE BENEFIT OF THE SPINALOGIC IS THAT YOU HAVE A GREATER CHANCE OF YOUR BACK SURGERY HEALING IF YOU USE THE DEVICE EVERY DAY THAN IF YOU DON NOT USE IT."
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