| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM |
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| Generic Name | Sensor, glucose, invasive |
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| Applicant | Abbott Laboratories
1360 S. Loop Rd.
Alameda, CA 94502 |
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| PMA Number | P050020 |
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| Supplement Number | S008 |
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| Date Received | 11/28/2008 |
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| Decision Date | 10/29/2009 |
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| Withdrawal Date | 03/18/2013 |
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| Product Code |
MDS |
| Advisory Committee |
Clinical Chemistry |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR A MODIFICATION TO THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSEMONITORING SYSTEM RECEIVER SOFTWARE. THE PRIMARY PURPOSE OF THE NEW SOFTWARE IS TO ALLOW USERS TO OBTAIN CONTINUOUS GLUCOSE DATA AS QUICKLY AS POSSIBLE AFTER INSERTION OF THE SENSOR. THE NEWALGORITHM CHANGES THE CALIBRATION TIME TO 1, 2, 10, 24 AND 72 HOURS, WITH GLUCOSE DATA BEINGAVAILABLE AT ONE HOUR. OTHER CHANGES ARE THE INCREASE TO ALLOWABLE RANGE FOR GLUCOSE CALIBRATION,INCREASE TO THE ALLOWABLE GLUCOSE RATE CHANGE AND THE ADDITION OF A CALIBRATION LAG CORRECTION.ADDITIONAL CHANGES WERE MADE TO THE RECEIVER SOFTWARE/USER INTERFACE; THE BACKLIGHT WILL NOWALWAYS BE ON WHEN THE RECEIVER IS DISPLAYING INFORMATION, THE SCREEN TIMEOUT WILL BE 20 SECONDS AND THERE WILL BE NO ABANDON ALARM FEATURE. |
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