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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.
 
DeviceCYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Classification Nameglucose oxidase, glucose
Generic Nameglucose oxidase, glucose
Regulation Number862.1345
Applicant
ANIMAS CORP.
200 lawrence dr.
west chester, PA 19380
PMA NumberP990026
Supplement NumberS012
Date Received01/16/2002
Decision Date02/04/2002
Product Code
CGA[ Registered Establishments with CGA ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE SAMPLING PLAN FOR INCOMING AND IN-PROCESS COMPONENTS AND FINISHED PRODUCTS.
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