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 | Intellis™ and Vanta™ Spinal Cord Stimulation Systems |
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 | S544 |
Date Received | 07/12/2023 |
Decision Date | 10/10/2023 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement minor design and manufacturing changes to metal strip resistors, Specifically, 1) Change in construction from a copper clad technology to a welded copper technology; and 2) Change in resistor height requirement |
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