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 | S051 |
Date Received | 04/01/2022 |
Decision Date | 04/28/2022 |
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 Update an analytical method used to evaluate a raw ingredient of the glucose sensor component and to introduce the evaluation process to an additional manufacturing site. The glucose sensor is a component of the FreeStyle Libre 14-Day and FreeStyle Libre Pro Glucose Monitoring Systems. |
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