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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceEBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP790005
Supplement NumberS041
Date Received06/24/1998
Decision Date07/24/1998
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revision of the indications and usage section ofthe labeling to include the definitiono f nonunion recommended by the orthopedic and rehabilitation devices panel on april 28, 1998 and required per fda's letter dated june 3, 1998 (i. E. , "a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing").
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