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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.
 
DeviceCOLLACOTE COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantINTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP840062
Supplement NumberS028
Date Received05/16/2013
Decision Date06/18/2013
Product Code LPG 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGES IN CLEANING DETERGENT, DIRTY EQUIPMENT HOLD TIMES, AND CLEANING METHODS.
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