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 CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | Abbott Laboratories 1360 South Loop Road Alameda, CA 94502 |
PMA Number | P050020 |
Supplement Number | S022 |
Date Received | 02/02/2010 |
Decision Date | 01/14/2011 |
Withdrawal Date
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03/18/2013 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE OUTGOING QUALITY CONTROL (QC) SOLUTION TESTING. |
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