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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameimplant, dermal, for aesthetic use
Generic Namecollagen for tissue augmentation
PMA NumberP800022
Date Received05/02/1980
Decision Date07/22/1981
Withdrawal Date 10/25/2011
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 81M-0237
Notice Date 09/18/1981
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S013 S015 S016 S017 S018 S020 S021 S022 
S023 S025 S027 S028 S029 S030 S032 S033 S034 
S035 S036 S038 S039 S040 S041 S042 S044 S045 
S046 S047 S048 S049 S050 S052 S053 S054 S055