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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 MAMMARY PROSTHESES
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMentor Worldwide, LLC
33 Technology Dr.
Irvin, CA 92618
PMA NumberP990075
Supplement NumberS028
Date Received10/22/2014
Decision Date11/19/2014
Product Code FWM 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO ADD AN ALTERNATE SUPPLIER FOR ISOPROPYL ALCOHOL (IPA) USED IN THE PRODUCTION OF SPECTRUM AND SALINE-FILLED BREAST IMPLANTS AT MENTOR'S IRVING, TEXAS FACILITY.
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