FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P050020/S031 · decided 2010-11-23
Approval details
- PMA number
- P050020
- Supplement
- S031
- 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
- 2010-10-25
- Decision date
- 2010-11-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Alameda, CA
- Statement
- CHANGE IN THE CLEANING PROCEDURE OF THE REACTORS USED TO MAKE THE NPBI MEDIATOR CHEMICAL USED IN THE FREESTYLE TEST STRIPS AND THE TIME FRAME IN WHICH THIS CLEANING PROCESS TAKES PLACE.
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