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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 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Namesilicone gel-filled breast implant
Regulation Number878.3540
ApplicantALLERGAN
PMA NumberP040046
Supplement NumberS008
Date Received08/11/2014
Decision Date11/07/2014
Product Code
FTR[ Registered Establishments with FTR ]
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 additional natrelle 410 device styles and sizes including: one (1) size of style fl 410; one (1) size of style ml 410; two (2) sizes of style ll 410; four (4) sizes of style lm 410; ten (10) sizes of style lf 410; nine (9) sizes of style fx 410; nine (9) sizes of style mx 410; and seven (7) sizes of style lx 410.
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