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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 PLUS 60/W AND SPF-PLUS 60/M
Classification Namestimulator, invasive bone growth
Generic Namesdpf implantable spinal fusion stimulator
ApplicantBIOMET, INC.
PMA NumberP850035
Supplement NumberS031
Date Received02/23/2007
Decision Date06/21/2007
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for device modifications to incorporate identical battery chemistry and implant tester configuration as approved in the spf-xl iib device. The device, as modified, will be marketed under the trade name spf-plus 60/w and spf-plus 60/m and is indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
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