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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEMORYSHAPE BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
ApplicantMENTOR WORLDWIDE LLC
PMA NumberP060028
Supplement NumberS002
Date Received09/23/2014
Decision Date10/29/2014
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to convert the manual barcode manufacturing process to an automated process to the mandrel used in the production of memoryshape, memorygel silicone gel-filled, spectrum and saline-filled breast implants manufactured at mentor's irving, texas facility.
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