|
Device | MODEL 3550-39 TITAN ANCHOR |
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 | S135 |
Date Received | 04/07/2009 |
Decision Date | 09/02/2009 |
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: 1) REMOVAL OF THE XYLENE MIXING STEP; 2) ADDITION OF A SECONDARY SILICONE ADHESIVE STEP AND CURE; AND 3) MODIFICATION OF THE INCOMING RECEIVING INSPECTION PROCESS WITH THE ADDITION OF A PROCESS MONITOR. |