FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P050020/S010 · decided 2009-09-25

Approval details

PMA number: P050020
Supplement: S010
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Trade name: FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic name: Sensor, glucose, invasive
Applicant: Abbott Laboratories
Date received: 2009-02-02
Decision date: 2009-09-25
Days to decision: 235 days
Decision code: APPR
Product code: MDS
Advisory committee: Clinical Chemistry
Expedited review: No
Location: Alameda, CA
Statement: APPROVAL NEW PACKAGING AND DESICCANT FOR THE INSERTER SUBCOMPONENT OF THE SENSOR DELIVERY UNIT (SDU), WHICH IS A COMPONENT OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS MODIFICATION TO THE ORIGINAL APPROVED DEVICE RESULTS IN A NEWSTERILIZATION CONFIGURATION, A NEW PACKAGE AND NEW STERILIZATION METHOD (EO) FOR THE SENSORSUPPORT MOUNT SUBCOMPONENT OF THE SDU, USER ASSEMBLY OF THE INSERTER WITH THE SENSOR SUPPORTMOUNT SECTION, NEW SECONDARY CONTAINERS FOR THE SUBCOMPONENTS O

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