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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.
 
DeviceSPF IMPLANTABLE BONE GROWTH STIMULATOR
Generic NameStimulator, invasive bone growth
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS025
Date Received03/31/2000
Decision Date09/27/2000
Product Code LOE 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISED LABELING BASED ON THE FINDINGS OF THE POST-APPROVAL STUDY FOR THE SPF(R) IMPLANTABLE BONE GROWTH STIMULATOR.
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