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 | S005 |
Date Received | 05/07/2008 |
Decision Date | 06/02/2008 |
Withdrawal Date
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03/18/2013 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE FOR MINOR MODIFICATIONS TO THE DEVICE COMPONENTS. |
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