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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.
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
399 jefferson road
parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS028
Date Received05/30/2000
Decision Date06/23/2000
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from a lithium iodine battery (crc 1935m) to a lithium manganese battery (renata, cr-2032amt207-1) in the spf(r) 2t, 4t and xliib spinal fusion stimulators.