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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 BIOGRAPHER
Generic NameGLUCOSE OXIDASE, GLUCOSE
Regulation Number862.1345
ApplicantAnimas Corp.
200 Lawrence Dr.
West Chester, PA 19380
PMA NumberP990026
Supplement NumberS016
Date Received12/13/2002
Decision Date12/31/2002
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 THE PCBA WASH PROCESS IN THE PCBA ASSEMBLY SEQUENCE TO INCREASE THE EFFICIENCY OF THE PROCESS AND TO REDUCE COST.
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