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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.
 
DeviceDRILAC{TM} CUBES / GRANULES
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantOsmed, Inc.
325 Lake Ave. S. - Suite
#608
Duluth, MN 55802
PMA NumberP800012
Supplement NumberS006
Date Received03/11/1993
Decision Date06/28/1994
Withdrawal Date04/25/2007
Product Code LPG 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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