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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 AUTOMATIC GLUCOSE BIOGRAPHER
Generic NameGLUCOSE OXIDASE, GLUCOSE
Regulation Number862.1345
ApplicantANIMAS CORP.
200 LAWRENCE DR.
WEST CHESTER, PA 19380
PMA NumberP990026
Supplement NumberS017
Date Received06/02/2003
Decision Date06/17/2003
Withdrawal Date 04/23/2010
Product Code CGA 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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