| 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 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters TDD (Drug Delivery Infusion Pump 8667), TDD (Drug Delivery I |
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| Generic Name | Pump, infusion, implanted, programmable |
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| Applicant | Medtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432 |
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| PMA Number | P860004 |
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| Supplement Number | S464 |
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| Date Received | 09/30/2026 |
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| Decision Date | 10/29/2026 |
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| Product Code |
LKK |
| Advisory Committee |
General Hospital |
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| Supplement Type | 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
1. Enhanced operator verification of the applicable FactoryWorks processing step and recorded battery pre-weight.2. Addition of pre-weight and post-weight out-of-control action plans to the applicable Process Operation Descriptions.3. Software and Human Machine Interface updates that will automatically reject batteries with fill weights above the established final-fill reasonable limit.4. Introduction of dedicated white work-in-progress trays to distinguish electrolyte-filled batteries and improve line clearance, handling, and traceability.5. Use of an isopropyl alcohol wipe to remove residual electrolyte from battery surfaces before subsequent processing.6. Removal of the Ball Press and Button Press certification prerequisites from the Ball and Button Press Ram Change procedure, allowing Medium Rate Line 2 operators to qualify for press ram changes by completing only the ram-change procedure while supervisors and engineers retain responsibility for operator certification |
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