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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.
 
Trade NameOSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namebone growth stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP790005
Supplement NumberS043
Date Received05/30/2000
Decision Date06/23/2000
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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