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 | SCS ACCESSORIES,SCS 1X8 EXTENSION,SCS QUADRIPOLAR EXTENSION,SCS LEADS SPECIFY FAMILY,SCS LEADS 1X8 FAMILY,SCS LEADS |
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 | S231 |
Date Received | 12/11/2012 |
Decision Date | 01/08/2013 |
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 USE AN UPDATED VERSION OF THE SOFTWARE ALREADY IN USE AT VARIOUS FACILITIES TO ENSURE COMPLIANCE TO TRAINING REQUIREMENTS, PROPER DOCUMENTATION ASSOCIATED WITH DISPOSITION OF PRODUCT, AND PROPER FUNCTION OF THE SOFTWARE BY CORRECTING MINOR ISSUES PRESENT IN THE CURRENT SOFTWARE VERSION. |
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