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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 NameNATRELLE SALINE-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namesilicone inflatable breast prosthesis
Regulation Number878.3530
ApplicantALLERGAN
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 - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the material used for the fill tube tip and luer adapter of the fill tube assembly for natrelle saline-filled breast implants from pro-fax pd626 polypropylene homopolymer to p5m6k-080 polypropylene copolymer.
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