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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 NameINSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
ApplicantAnimas Corp.
200 Lawrence Dr.
West Chester, PA 19380
PMA NumberP990026
Supplement NumberS019
Date Received07/07/2003
Decision Date08/28/2003
Withdrawal Date04/23/2010
Product Code NCT 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF A POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.
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