FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P050020/S017 · decided 2010-01-19
Approval details
- PMA number
- P050020
- Supplement
- S017
- Supplement type
- Real-Time Process
- 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
- 2009-06-17
- Decision date
- 2010-01-19
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- APPROVAL FOR A PROCESS VALIDATION ON THE SHARP MANUFACTURED AT OBERG INDUSTRIES (IN FREEPORT, PENNSYLVANIA) AS WELL AS TO WIDEN DIMENSIONAL TOLERANCES ON THE SHARP IN BOTH LENGTH AND ANGLE BEND. CURRENTLY ALL SHARPS PRODUCED AT OBERG MUST UNDERGO 100% INSPECTION AT FACET (IN MARIETTA, GEORGA) PRIOR TO ITS ASSEMBLING INTO THE SENSOR INSERTER OF THE SENSOR DELIVERY UNIT (SDU) OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THE PROCESS VALIDATION PROVIDED IN THIS SUPPLEMENT WILL RE
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