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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 IMPLANT
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namesilicone inflatable breast prosthesis
Regulation Number878.3530
ApplicantALLERGAN
PMA NumberP990074
Supplement NumberS018
Date Received02/23/2007
Decision Date05/17/2007
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a trade name change from inamed saline-filled breast implants to natrelle saline-filled breast implants. The device, as modified, will be marketed under the trade name natrelle saline-filled breast implants and is indicated for 1) breast augmentation for women 18 years or older; and 2) breast reconstruction.
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