|
Device | SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY |
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 | S254 |
Date Received | 10/22/2013 |
Decision Date | 11/20/2013 |
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 CHANGES TO THE MANUFACTURING TEST METHODOLOGY (FINAL FUNCTIONAL TEST) FOR HYBRIDS THAT ARE USED TO BUILD IMPLANTABLENEUROSTIMULATORS. |