|
Device | ITREL3,SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR INPLANTABLE NEUROSTIMULATOR |
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 | S099 |
Date Received | 09/17/2007 |
Decision Date | 01/11/2008 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHYLENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS. |