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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:  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