|
Device | KINETRA & SOLETRA FAMILY OF NEUROSTIMULATOR |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S043 |
Date Received | 09/17/2007 |
Decision Date | 01/11/2008 |
Product Code |
MHY |
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. |