|
Device | Guardian Sensor 3 |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P160007 |
Supplement Number | S043 |
Date Received | 12/09/2021 |
Decision Date | 12/16/2022 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of Medtronic Puerto Rico Operations Co. as a manufacturing site for the sensor fabrication process for the Guardian Sensor (3). The Guardian Sensor (3) is a component of the MiniMed 670G and 770G Systems, the Guardian Connect System, and the MiniMed 630G System. |