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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 NumberS007
Date Received08/28/2001
Decision Date10/25/2001
Withdrawal Date04/23/2010
Product Code CGA 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT CYGNUS, INC., REDWOOD, CALIFORNIA.
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