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 | MEDTRONIC ITREL SPINAL CORD STIMULATION 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 | S062 |
Date Received | 05/20/2002 |
Decision Date | 07/25/2002 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 3550-16 EZ ANCHOR ACCESSORY KIT WHICH WILL BE LABELED FOR USE WITH THE FOLLOWING MEDTRONIC, INC. LEADS: PISCES-QUAD MODEL 3487A, RESUME MODEL 3587A, TEMPORARY SCREENING LEAD MODEL 3861, PISCES-QUAD COMPACT MODEL 3887, PISCES-QUAD PLUS MODEL 3888 AND THE PISCES-OCTAD MODEL 3898. THE MODEL 3550-16 EZ ANCHOR IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS. |
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