FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P050020/S002 · decided 2008-05-15

Approval details

PMA number: P050020
Supplement: S002
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: 2008-04-02
Decision date: 2008-05-15
Days to decision: 43 days
Decision code: APPR
Product code: MDS
Advisory committee: Clinical Chemistry
Expedited review: No
Location: Alameda, CA
Statement: APPROVAL FOR: 1) THE ADDITION OF A CARBON COATING TO THE BACK OF THE SENSOR TAIL TO IMPROVE ADHESION OF THE MEMBRANE IN ORDER TO ELIMINATE MICROSCOPIC MEMBRANE FRAGMENTATION; 2) A CHANGE IN THE ORIENTATION OF THE POSITION OF THE SENSOR DURING THE MANUFACTURING PROCESS TO FACILITATE INSPECTION; 3) A LABELING CHANGE, RESULTING FROM THE BACKSIDE CARBON COATING, TO ELIMINATE A CAUTION REGARDING MEMBRANE FRAGMENTS REMAINING IN THE SKIN; 4) AND A CHANGE IN A SUB-SUPPLIER MANUFACTURING SITE, DUPONT, HO

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