FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P050020/S009 · decided 2009-03-06
Approval details
- PMA number
- P050020
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Abbott Laboratories
- Date received
- 2008-12-24
- Decision date
- 2009-03-06
- Days to decision
- 72 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- CHANGES TO THE CLEAN ROOM ENVIRONMENTAL MONITORING PROGRAM CURRENTLY DESCRIBED IN DOC04098 FOR THE DEVICE.
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