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. |
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Device | RESTORE RECHARGEABLE,RESTORE PRIME,RESTORE,ADVANCED,PRIME ADVANCED,RESTORE ULTRA,ITREL 4,SYNERGY,SYNERGY VERSTIREL |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S225 |
Date Received | 08/14/2012 |
Decision Date | 09/12/2012 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE THE ACCEPTANCE CRITERIA FOR TITANIUM CONTENT IN THE CABLES AND TO ADD AN ALTERNATE SUPPLIER FOR THE CABLE BRAIDING AND MICRO-EXTRUSION PROCESSES. |
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