| 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 System |
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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 | S070 |
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| Date Received | 08/21/2019 |
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| Decision Date | 08/26/2019 |
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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
Addition of new sterilization equipment at two previously approved sterilization facilities for the sterilization of the Enlite and Guardian Sensor (3) continuous glucose monitoring sensors. The Enlite sensor is a component of the MiniMed 530G system, the MiniMed 630G system, the Paradigm Real-Time Revel system, and the iPro2 with Enlite sensor system. The Guardian Sensor (3) is a component of the MiniMed 630G system, the Guardian Connect system, and the MiniMed 670G system. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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