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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 NumberS022
Date Received02/26/2004
Decision Date06/22/2004
Withdrawal Date 04/23/2010
Product Code NCT 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MULTIPLE-PATIENT USE OF THE GLUCOWATCH G2 BIOGRAPHER.
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