| 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 | MiniMed 670G Pump |
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| Generic Name | Automated insulin dosing device system, single hormonal control |
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| Applicant | Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325 |
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| PMA Number | P160017 |
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| Supplement Number | S012 |
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| Date Received | 04/10/2017 |
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| Decision Date | 05/10/2017 |
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| Product Code |
OZP |
| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT02130284
|
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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 | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
Transfer equipment used for leak testing seals of the Paradigm insulin infusion pumps and Next Generation insulin infusion pumps from Medtronic MiniMed to a sub-tier supplier, as well as transferring the task of performing such testing to the sub-tier supplier. The Paradigm insulin infusion pump is component of the Paradigm REAL-Time System, the Paradigm REAL-Time Revel System, and the MiniMed 530G System. The Next Generation insulin infusion pump is a component of the MiniMed 630G System and the MiniMed 670G System. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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