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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 NameITREL & RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
PMA NumberP840001
Supplement NumberS110
Date Received03/26/2008
Decision Date04/25/2008
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a paperless chart recorder to the sterilization operations at the medtronic puerto rico operations company, villalba manufacturing facility.
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