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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSpF® Implantable Spinal Fusion Stimulator
Generic NameStimulator, invasive bone growth
ApplicantAhp Eos Buyer, Inc.
1 Gatehall Dr.
Suite 303
Parsippany, NJ 07054
PMA NumberP850035
Date Received05/31/1985
Decision Date04/30/1987
Product Code LOE 
Docket Number 87M-0174
Notice Date 06/10/1987
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Supplements: S022 S002 S003 S004 S005 S006 S007 S008 S010 S012 S013 S016 
S017 S018 S019 S020 S021  S029 S030 S032 S033 S024 S023 
S025 S028 S044 S031 S045 S043 S048 S049 S055 S057 S058 S059 
S046 S047 S050 S051 S052 S053 S040 S041 S034 S039 S035 S038 
S054 S036 S056 S042 
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