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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 CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMentor Worldwide, LLC
33 Technology Dr.
Irvin, CA 92618
PMA NumberP990075
Supplement NumberS036
Date Received03/17/2016
Decision Date04/15/2016
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  
Update to the PROC000331 Packaging with Alloyd Heat Sealers and Tyvek Pouch to implement the use of Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices.
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