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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 NumberS020
Date Received05/24/2010
Decision Date06/22/2010
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  
CHANGE IN MANUFACTURING EQUIPMENT.
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