|
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 | S031 |
Date Received | 10/25/2010 |
Decision Date | 11/23/2010 |
Withdrawal Date
|
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 |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE IN THE CLEANING PROCEDURE OF THE REACTORS USED TO MAKE THE NPBI MEDIATOR CHEMICAL USED IN THE FREESTYLE TEST STRIPS AND THE TIME FRAME IN WHICH THIS CLEANING PROCESS TAKES PLACE. |