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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.
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Namesilicone gel-filled breast implant
Regulation Number878.3540
PMA NumberP040046
Supplement NumberS009
Date Received09/15/2014
Decision Date03/13/2015
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following packaging and manufacturing changes: 1) modification of the primary inner and outer tray packaging to include two finger tabs; 2) modification of the outer tray to include two cavities; 3) a change of the polycarbonate tray material to geox peerex® 51 pc polycarbonate film to be supplied by prent thermoforming; 4) primary lid packaging that is larger with blue ink arrows; 5) larger secondary packaging boxes to house the larger trays; 6) a change to a separate tamper evident label, i. E. , the product labels no longer serve as a tamper evident label; and 7) changes to the heat sealing process (new parameters: temperature = 236-256 degree f, dwell time = 4. 9-6. 9 s, pressure = 60-80 psi).