Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM |
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 | S047 |
Date Received | 06/01/2000 |
Decision Date | 02/21/2001 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXPANSION OF THE INDICATIONS FOR USE OF THE MEDTRONIC MODEL 7421 ITREL, 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION SYSTEMS. THESE DEVICES ARE NOW INDICATED "AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BCK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME OR HERNIATED DISC, POST-LAMINECTOMY PAIN, MULTIPLE BACK OPERATIONS, UNSUCCESSFUL DISC SURGERY, DEGENERATIVE DISC DISEASE (DDD/HERNIATED DISC PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS, PERIPHERAL CAUSALGIA, EPIDURAL FIBROSIS, ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS, COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA". |
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