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 | S002 |
Date Received | 04/02/2008 |
Decision Date | 05/15/2008 |
Withdrawal Date
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03/18/2013 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) THE ADDITION OF A CARBON COATING TO THE BACK OF THE SENSOR TAIL TO IMPROVE ADHESION OF THE MEMBRANE IN ORDER TO ELIMINATE MICROSCOPIC MEMBRANE FRAGMENTATION; 2) A CHANGE IN THE ORIENTATION OF THE POSITION OF THE SENSOR DURING THE MANUFACTURING PROCESS TO FACILITATE INSPECTION; 3) A LABELING CHANGE, RESULTING FROM THE BACKSIDE CARBON COATING, TO ELIMINATE A CAUTION REGARDING MEMBRANE FRAGMENTS REMAINING IN THE SKIN; 4) AND A CHANGE IN A SUB-SUPPLIER MANUFACTURING SITE, DUPONT, HOPEWELL, VIRGINIA. |
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