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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.
 
DeviceIDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantIDEALIMPLANT
14881 quorum drive suite 925
dallas, TX 75254
PMA NumberP120011
Supplement NumberS003
Date Received03/28/2016
Decision Date11/17/2016
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for re-sterilization of the IDEAL IMPLANT® Saline-filled Breast Implant up to a total of 44 hours exposure time if the primary dry heat sterilization (DHS) cycle is interrupted and/or aborted
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