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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, inflatable, internal, saline
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
2525 dupont dr.
irvine, CA 92612
PMA NumberP990074
Supplement NumberS028
Date Received12/31/2013
Decision Date03/27/2014
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the material used for the fill tube tip andluer adapter of the fill tube assembly for natrelle saline-filled breast implants from pro-fax pd626 polypropylene homopolymer to p5m6k-080 polypropylene copolymer.