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 PRO FLASH GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | Abbott Diabetes Care Inc. 1360 SOUTH LOOP RD. ALAMEDA, CA 94502 |
PMA Number | P150021 |
Supplement Number | S004 |
Date Received | 12/16/2016 |
Decision Date | 05/31/2017 |
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 to increase the sensor manufacturing capacity, at the manufacturing facility ADC Witney, by implementing a high volume sensor manufacturing line setup. The change included updates to the printed flex circuit processing equipment, qualification of a new ISO 8 cleanroom, implementation of new manufacturing and support equipment, and introduction of a new sampling machine. The sensor is a component of the Freestyle Libre Pro Flash Glucose Monitoring System. |
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