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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namecollagen wound dressing
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP840062
Supplement NumberS007
Date Received08/18/2000
Decision Date12/07/2000
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
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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