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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceGLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Classification Nameinstrument, glucose, noninvasive technology
Generic Nameinstrument, glucose, noninvasive technology
Applicant
ANIMAS CORP.
200 lawrence dr.
west chester, PA 19380
PMA NumberP990026
Supplement NumberS020
Date Received08/01/2003
Decision Date08/20/2003
Product Code
NCT
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the manufacturing process of the glucowatch biographer autosensor to add a secondary visual inspection of the autosensors rejected by the automated, camera-based inspection to increase product yield and reduce production costs.
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