| 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 | Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006) |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | MEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432 |
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| PMA Number | P840001 |
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| Supplement Number | S535 |
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| Date Received | 12/22/2022 |
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| Decision Date | 09/22/2023 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for adding a new requirement and new behavior to the firmware and changing the `Stim off Charge Pump Amplitude' from the maximum value to the minimum value. When stimulation is off, the Charge Pump will be set to the minimum value. Adding a new risk control measure and new behavior to the firmware. Every 5 minutes the firmware will now reset the Tel-N Phase Lock Loop (PLL). The interface and requirement will also be changed, and new behavior will be added to the firmware. When the relevant Tel-N command is received by the INS, the Tel-M module will be disabled for 5 seconds and then re-enabled. Fixing the cap balance routine configuration value to determine whether it was enabled. Updating so that a device with corrupt flash (with ECC errors) in the code space will be able to be updated over the air without causing an unexpected reset. Updating behavior so that stimulation will no longer lock up if the lead integrity test is canceled too soon. Updating a library code function that may cause a loss of data on the Serial Peripheral (SPI) bus if used. Updating behavior so group changes are always logged, even when therapy is off. INS behavior will also be changed so aDBS programs are applied correctly when the programs are enabled regardless of which aDBS program is reenabled first. Updating behavior so the Enable/disable aDBS program command works correctly and updates the settings for the sense group that was modified, but only applies the new settings to the runtime settings if the group whose settings were changed is the active group. Updating behavior so backup sensing settings are stored properly and reverting the settings works. |
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