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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.
 
DeviceTELECTRONICS OSTEOSTIM BONW GROWTH STIMULATOR MODE
Generic NameStimulator, invasive bone growth
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP790005
Supplement NumberS004
Date Received12/16/1980
Decision Date02/03/1981
Product Code LOE 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
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