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 | Freestyle Libre 14-Day Flash Glucose Monitoring System |
Generic Name | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated |
Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP DR. ALAMEDA, CA 94502-7000 |
PMA Number | P160030 |
Supplement Number | S049 |
Date Received | 02/01/2022 |
Decision Date | 03/02/2022 |
Product Code |
PZE |
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 manufacture of a sensor membrane polymer component. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System. |
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