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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 3/SYNERGY/RESTORE PRIME/PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE NEUROSTIMULATOR
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS127
Date Received01/02/2009
Decision Date01/26/2009
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 
Change in the sterilization process at the facility located in juncos, puerto rico.
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