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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.
 
DeviceMENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMentor Worldwide, LLC
33 Technology Dr.
Irvin, CA 92618
PMA NumberP990075
Supplement NumberS029
Date Received10/27/2014
Decision Date11/26/2014
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE WINGED INFUSION SET ACCESSORY OF THE MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT. THE MODIFICATIONS INCLUDED: 1. TEXTURE, BEVELED EDGES, AND A FINGER HOLE WAS ADDED TO EACH (2) SIDE OF THE WING DESIGN; 2. PHTHALATE WAS ELIMINATED FROM THE WING MATERIAL: PVC NAKAN FEM 828 N N WITH DEHP WITH COLORANT MASTERBATCH PVC 9154 GREEN TO PVC NAKAN FEM 828 N N WITH DEHT WITH COLORANT MASTERBATCH PVC 9154 GREEN; AND3. PHTHALATE WAS ELIMINATED FROM THE TUBING MATERIAL: PVC NAKAN FMA 748 N N WITH DEHP TO PVC NAKAN FMA 748 N N WITH DEHT.
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