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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRESTORE, RESTOREPRIME, RESTOREADVANCED, RESTORE PRIME ADVANCED, AND RESTOREULTRA NEUROSTIMULATION SYSTEMS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS122
Date Received10/08/2008
Decision Date12/08/2008
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF A STABILIZING COIL TO THE MODEL 37083 EXTENSION, A ¿POST-CURE¿ PROCESSING STEP AT THE DISTAL END OF THE MODELS 37083 AND 37082 EXTENSIONS, AND A PROXIMAL BOND STRENGTH (THERMAL BOND) DESIGN REQUIREMENT FOR MODELS 37083 AND 37082 EXTENSIONS.
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