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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.
 
DeviceOSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR
Generic NameStimulator, invasive bone growth
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP790005
Supplement NumberS043
Date Received05/30/2000
Decision Date06/23/2000
Product Code LOE 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE FROM A LITHIUM IODINE BATTERY (CRC 1935M) TO A LITHIUM MANGANESE BATTERY (RENATA, CR-2032AMT207-1) IN THE OSTEOGEN BONE GROWTH STIMULATORS.
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