| 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 and Ascenda Intrathecal Catheters |
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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 | S368 |
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| Date Received | 01/25/2021 |
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| Decision Date | 08/30/2021 |
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| Product Code |
LKK |
| Advisory Committee |
General Hospital |
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| Supplement Type | 135 Review Track For 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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| Recalls | CDRH Recalls |
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Approval Order Statement
Approval for a cleaning process change at DSM Biomedical in Berkeley California, a supplier to Medtronic Neuromodulation, that involves the addition of an option to replace solvent cleaning the equipment between material lots with a process that uses the next lot of material to purge the system (the first 30 seconds of material coming out of this portion of the manufacturing line is discarded). The change involves the continuous reactor system to be purged between production batches of same hardness grade and purged and cleaned between production batches of different hardness. |
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