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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 NameCONNECTOR-M1
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantADVANCED BIONICS CORP.
PMA NumberP030017
Supplement NumberS025
Date Received06/20/2007
Decision Date10/30/2007
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the precision omg (observational mechanical gateway) connector-m1, models sc-9004-35, sc-9004-55, and sc-9004-70.
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