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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 CUBES AND GRANULES
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantOsmed, Inc.
325 Lake Ave. S. - Suite
#608
Duluth, MN 55802
PMA NumberP800012
Supplement NumberS010
Date Received09/09/2002
Decision Date10/09/2002
Withdrawal Date04/25/2007
Product Code LPG 
Advisory Committee Dental
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE LABELING.
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