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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 PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)
Generic NameStimulator, invasive bone growth
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS033
Date Received07/22/2008
Decision Date09/18/2008
Product Code LOE 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE TRADE NAME WHICH WAS PREVIOUSLY APPROVED AS: SPF-PLUS (60/W) AND SPF- PLUS (60/M). THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M) AND IS INDICATED AS A SPINAL FUSING ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS.
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