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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, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantIntegra Lifesciences Corp.
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP840062
Supplement NumberS031
Date Received07/31/2013
Decision Date08/29/2013
Product Code LPG 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.
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