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 II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS |
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 | S061 |
Date Received | 05/10/2002 |
Decision Date | 10/31/2002 |
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 THE MODEL 8870 N'VISION APPLICATION CARD. THE MODEL 8870 N'VISION APPLICATION CARD IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS. |
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