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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 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.
 
DeviceGLUCOWATCH G2 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 NumberS014
Date Received08/08/2002
Decision Date08/23/2002
Product Code
CGA[ Registered Establishments with CGA ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE AUTOSENSOR FROM 6 MONTHS TO 18 MONTHS.
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