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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSPF IMPLANTABLE BONE GROWTH STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namesdpf implantable spinal fusion stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP850035
Supplement NumberS025
Date Received03/31/2000
Decision Date09/27/2000
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
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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