|
Device | FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | Abbott Laboratories 1360 South Loop Road Alameda, CA 94502 |
PMA Number | P050020 |
Supplement Number | S021 |
Date Received | 12/22/2009 |
Decision Date | 01/11/2010 |
Withdrawal Date
|
03/18/2013 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES FOR THE FREESTYLE NAVIGATOR USER¿S GUIDE AS FOLLOWS: 1) ADDITION OF THE STATEMENT UNDER THE ¿SPECIFICATIONS¿ SECTION¿ ¿STORE THE TEST STRIPS BETWEEN 40 DEGREES F AND 86 DEGREES F.¿; 2) ADDITION OF THE STATEMENT UNDER THE ¿IMPORTANT NOTES¿ SECTION: ¿THE SYSTEM IS INTENDED FOR YOUR PERSONAL USE; DO NOT SHARE YOUR SYSTEM WITH OTHERS.¿ |