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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDRILAC CUBES AND GRANULES
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namepolylactic acid surgical dressing material
ApplicantKENSEY NASH CORP.
PMA NumberP800012
Supplement NumberS010
Date Received09/09/2002
Decision Date10/09/2002
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the directions for use labeling.
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