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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSALINE-FILLED BREAST IMPLANTS
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantAllergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP990074
Supplement NumberS013
Date Received08/09/2002
Decision Date08/23/2002
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF 1) STYLES 68HP AND 68LP AND 2) CORRESPONDING PACKAGE LABELING.
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