Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: ITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM
• Classification Name: stimulator, spinal-cord, totally implanted for pain relief
• Applicant: MEDTRONIC INC.
• PMA Number: P840001
• Supplement Number: S211
• Date Received: 04/05/2012
• Decision Date: 05/30/2012
• Product Code: LGW [ Registered Establishments with LGW ]
• Advisory Committee: Neurology
• Supplement Type: real-time process
• Supplement Reason: design change - minor
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for itrel 4 neurostimulators, models 37703 and 37704. The devices, as modified, will be marketed under the trade names itrel 4 neurostimulators, models 37703 and 37704 and are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: 1) failed back syndrome (fbs) or low back syndrome or failed back; 2) radicular pain syndrome or radiculopathies resulting in pain secondary to fbs or herniated disk; 3) postlaminectomy pain; 4) multiple back operations; 5) unsuccessful disk surgery; 6) degenerative disk disease (ddd)/herniated disk pain refractory to conservative and surgical interventions; 7) peripheral causalgia; 8) epidural fibrosis; 9) arachnoiditis or lumbar adhesive arachnoiditis; 10) complex regional pain syndrome (crps); 11) reflex sympathetic dystrophy (rsd), or 11) causalgia.