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 Sensor 3 |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P160007 |
Supplement Number | S049 |
Date Received | 12/01/2023 |
Decision Date | 01/03/2024 |
Product Code |
MDS |
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 a change to automate the tray sealing and lid printing process for the Guardian Sensor 3 and the Guardian 4 sensor. The Guardian Sensor 3 is a component of the MiniMed 630G, MiniMed 670G, MiniMed 770G, MiniMed 780G and Guardian Connect systems. The Guardian 4 Sensor is a component of the MiniMed 780G System |
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