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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 NameCOLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namecollagen wound dressing
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP840062
Supplement NumberS006
Date Received07/25/1995
Decision Date09/08/1995
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization facility for collacote, collatape and collaplug dressings at friffith microscience, inc. , 27 park road, glen falls, ny 12801.
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