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 4 Sensor |
Generic Name | Automated insulin dosing device system, single hormonal control |
Applicant | MEDTRONIC MINIMED, INC. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325 |
PMA Number | P160017 |
Supplement Number | S111 |
Date Received | 06/09/2023 |
Decision Date | 07/06/2023 |
Product Code |
OZP |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of an alternate manufacturing site for the sensor fabrication process for the Guardian 4 Sensor (G4S). The G4S is a component of the MiniMed 780G System. |
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