|
Device | SPINAL CORD STIMULATION THERAPY |
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 | S143 |
Date Received | 01/07/2010 |
Decision Date | 03/04/2010 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE REFORMULATION OF THE HOTMELT ADHESIVE USED FOR THE MEDTRONIC NEUROMODULATION STERILE BARRIER BLISTER PACKAGES. |