FRESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P050020/S032 · decided 2011-05-16
Approval details
- PMA number
- P050020
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Abbott Laboratories
- Date received
- 2010-12-02
- Decision date
- 2011-05-16
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- APPROVAL FOR CHANGES TO THE QUALITY SYSTEM DRAWINGS OF TEN RECEIVER AND TRANSMITTER COMPONENTS, USED FOR FIRST ARTICLE INSPECTION ACTIVITIES PRIOR TO RELEASE FOR MANUFACTURING.
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