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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.
 
DeviceHELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantINTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP840062
Supplement NumberS007
Date Received08/18/2000
Decision Date12/07/2000
Product Code LPG 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL TRADE NAME FOR COLLACOTE, COLLATAPE AND COLLAPLUG. THESE DEVICES WILL ALSO BE KNOWN AS HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY. THE SIZES OF THE WOUND DRESSINGS WILL BE IDENTICAL TO THE THREE COLLACOTE PRODUCTS. THERE WILL BE NO CHANGES IN THE DEVICE EXCEPT THE USE OF AN ADDITIONAL NEW TRADE MANE.
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