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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.
 
DeviceORATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namematerial, dressing, surgical, polylactic acid
Applicant
COLLA-TEC, INC.
p.o. box 688
plainsboro, NJ 08536
PMA NumberP840062
Supplement NumberS021
Date Received08/27/2010
Decision Date12/03/2010
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITIONAL TRADE NAME, ORATAPE, TO THE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY PRODUCT.
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