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 | 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 | S041 |
Date Received | 07/24/1997 |
Decision Date | 01/20/1998 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of an alternative packaging material, uncoated PETG (polyethylene terephthalate, glycol modifed) for the manufacture of the inner and outer packaging trays. The device, as modified, will be marketed under the trade name Itrel and is indicated for Spinal Cord Stimulation. |
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