|
Device | IMPLANTABLE NEUROSTIMULATORS FOR SPINAL CORD STIMULATION |
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 | S142 |
Date Received | 12/14/2009 |
Decision Date | 01/13/2010 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement INCREASING THE BAKE TIME FOR CERAMIC SUBSTRATES PRIOR TO THE SOLDER PREP REFLOW AND ADDING AN ADDITIONAL BAKE AFTER THE CLEAN AND DRY PROCESSING STEP. |