|
Device | INTREL 3 IMPLANTABLE NEUROSTIMULATORS/SYNERGY/RESTORE FAMILIES OF IMPLANTABLE NEUROSTIMULATORS |
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 | S203 |
Date Received | 12/21/2011 |
Decision Date | 01/20/2012 |
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 | Yes |
Recalls | CDRH Recalls |
Approval Order Statement THERMAL PROCESSING OF ECCOBOND EPOXY RESIN E3450(A) PRIOR TO CONSUMPTION IN ROUTINE MANUFACTURING. |