|
Device | MEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS |
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 | S037 |
Date Received | 01/17/1995 |
Decision Date | 08/29/1995 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MEDTRONIC ITREL 3 SPINAL CORD STIMULATION (SCS) SYSTEM FOR THE TREATMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND OR LIMBS |