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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 NameINSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
ApplicantAnimas Corp.
200 Lawrence Dr.
West Chester, PA 19380
PMA NumberP990026
Supplement NumberS020
Date Received08/01/2003
Decision Date08/20/2003
Withdrawal Date04/23/2010
Product Code NCT 
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 TO THE MANUFACTURING PROCESS OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR TO ADD A SECONDARY VISUAL INSPECTION OF THE AUTOSENSORS REJECTED BY THE AUTOMATED, CAMERA-BASED INSPECTION TO INCREASE PRODUCT YIELD AND REDUCE PRODUCTION COSTS.
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