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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.
 
DeviceSpectrum Saline Breast Implants
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMentor Worldwide, LLC
33 Technology Dr.
Irvin, CA 92618
PMA NumberP990075
Supplement NumberS042
Date Received07/12/2017
Decision Date08/09/2017
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  
Supplier change for Room Temperature Vulcanization (RTV) adhesive that is used in the assembly of Mentor® Spectrum® Saline Breast Implants with a kink valve. The current supplier location is Applied Silicone Corporation (ASC) located in Santa Paula, California. The new supplier location will be the Nusil Technology facility located in Carpinteria, California.
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