| 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 | Proclaim™ Spinal Cord Simulation Implantable Pulse Generator (IPG) |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | ABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024 |
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| PMA Number | P010032 |
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| Supplement Number | S227 |
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| Date Received | 10/15/2024 |
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| Decision Date | 01/13/2025 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for firmware version 1.3 and OneApp version 4.1, which include an expanded impedance range and updated trim values used for Magnetic Resonance Imaging (MRI) Mode, updated Elective Replacement Indicator requirement for Orion IPG systems, and labeling updates to account for these changes. You are also proposing to add a check for the MR conditional status of the combination of leads and Implanted Pulse Generators before entering MRI Mode, specify spinal cord stimulation therapy type for two MR Conditional leads (Models 3292 & 3219), define six legacy leads in the OneApp code, and add a program validation check during a Virtual Clinic session to OneApp |
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