| 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 | Guardian Connect System |
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| Generic Name | Sensor, glucose, invasive |
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| Applicant | Medtronic Minimed
18000 Devonshire St.
Northridge, CA 91325 |
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| PMA Number | P160007 |
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| Supplement Number | S010 |
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| Date Received | 10/15/2018 |
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| Decision Date | 11/14/2018 |
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| Product Code |
MDS |
| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT02246582
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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
Manufacturing facility move at one of Medtronics tier one supplier for the manual needle-hub assembly and one-press serter base component. The one-press serter is a component of the Enlite Sensor and Guardian Sensor (3). The needle-hub assembly component is used in the Medtronic Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of the Medtronic MiniMed 530G, 630G with SmartGuard, Paradigm Real-Time Revel System and iPro2 Continuous Glucose Monitoring Systems and Guardian Sensor (3) are components of the Medtronic MiniMed 670G and MiniMed 630G Continuous Glucose Monitoring Systems |
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