FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P050020/S011 · decided 2009-04-13
Approval details
- PMA number
- P050020
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Abbott Laboratories
- Date received
- 2009-02-23
- Decision date
- 2009-04-13
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT NUTEK CORPORATION, HAYWARD, CALIFORNIA, TO PERFORM STERILIZATION OF THE SENSOR DELIVERY UNIT.
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