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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.
 
DeviceCARIDEX(TM) REMOVAL SYSTEM
Generic Namesolution, removal, carries
ApplicantINDEVUS PHARMACEUTICALS, INC.
8 clarke dr.
cranbury, NJ 08512
PMA NumberP830035
Supplement NumberS003
Date Received06/06/1986
Decision Date11/25/1987
Withdrawal Date 10/22/2007
Product Code LMW 
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
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