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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 NumberS006
Date Received08/15/2001
Decision Date09/04/2001
Withdrawal Date04/23/2010
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN SUPPLIER OF GLUCOSE OXIDASE FOR THE AUTOSENSOR TO TOYOBO RESEARCH CENTER CO. LTD.
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