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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namebone growth stimulator
ApplicantEBI, L.P.
PMA NumberP850035
Date Received05/31/1985
Decision Date04/30/1987
Product Code
LOE[ Registered Establishments with LOE ]
Docket Number 87M-0174
Notice Date 06/10/1987
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
Supplements: S002 S003 S004 S005 S006 S007 S008 S010 S012 
S013 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S028 S029 S030 S031 S032 S033 S034 
S035 S036 
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