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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic Nameimplant, dermal, for aesthetic use
71 south los carneros road
goleta, CA 93117-5506
PMA NumberP800022
Date Received05/02/1980
Decision Date07/22/1981
Withdrawal Date 10/25/2011
Product Code LMH 
Docket Number 81M-0237
Notice Date 09/18/1981
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements:  S054 S055 S050 S053 S052 S042 S041 S040 
S039 S038 S036 S035 S034 S033 S032 S030 S029 
S028 S027 S025 S023 S022 S021 S020 S018 S017 
S016 S015 S013 S011 S009 S008 S007 S006 S005 
S004 S003 S002 S001 S047 S049 S048 S046 S045