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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 Nameglucose oxidase, glucose
Generic Nameglucose oxidase, glucose
Regulation Number862.1345
Applicant
ANIMAS CORP.
200 lawrence dr.
west chester, PA 19380
PMA NumberP990026
Supplement NumberS017
Date Received06/02/2003
Decision Date06/17/2003
Product Code
CGA[ Registered Establishments with CGA ]
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 an equivalent in-house supplier of the raw material platinum/carbon (pt/c) composite electrode ink for the manufacture of the glucowatch biographer autosensor.
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