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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 SPECTRUM AND SALINE-FILLED BREAST IMPLANTS
Generic NameProsthesis, breast, inflatable, internal, saline
Regulation Number878.3530
ApplicantMENTOR WORLDWIDE LLC
33 Technology Drive
Irvine, CA 92618
PMA NumberP990075
Supplement NumberS031
Date Received12/08/2014
Decision Date12/16/2014
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
Approval Order Statement  
CHANGE TO AUTOMATE THE MANUAL SECONDARY PACKAGING PROCESS TO BE USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IM LANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
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