NATRELLE Silicone-Filled Breast Implants

FDA Premarket Approval P020056 S053

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

The addition of new ovens used in the manufacturing process of natrelle silicone-filled breast implants

DeviceNATRELLE Silicone-Filled Breast Implants
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantAllergan
Date Received2021-03-12
Decision Date2021-04-10
PMAP020056
SupplementS053
Product CodeFTR 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Allergan 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P020056Original Filing
S053 2021-03-12 30-day Notice
S052
S051 2020-06-30 30-day Notice
S050
S049 2019-06-06 30-day Notice
S048 2018-07-02 30-day Notice
S047
S046 2017-12-18 135 Review Track For 30-day Notice
S045 2017-10-02 30-day Notice
S044 2017-07-20 30-day Notice
S043 2017-07-03 30-day Notice
S042 2017-06-07 30-day Notice
S041 2017-04-13 135 Review Track For 30-day Notice
S040 2017-03-01 Normal 180 Day Track
S039
S038 2016-11-23 Real-time Process
S037 2016-11-07 30-day Notice
S036 2016-09-30 Real-time Process
S035 2016-09-07 Special (immediate Track)
S034 2016-06-27 Real-time Process
S033 2016-05-17 30-day Notice
S032 2015-12-30 Normal 180 Day Track No User Fee
S031 2014-12-05 Normal 180 Day Track
S030
S029 2014-10-15 Normal 180 Day Track No User Fee
S028 2014-09-29 30-day Notice
S027 2014-09-15 Normal 180 Day Track
S026 2014-08-29 Normal 180 Day Track
S025 2014-05-30 Normal 180 Day Track No User Fee
S024 2014-01-17 30-day Notice
S023 2013-10-08 Normal 180 Day Track No User Fee
S022 2013-06-12 30-day Notice
S021 2013-05-21 30-day Notice
S020 2013-05-20 30-day Notice
S019 2013-02-26 30-day Notice
S018 2012-12-31 Normal 180 Day Track No User Fee
S017 2012-05-29 30-day Notice
S016 2012-01-25 Normal 180 Day Track No User Fee
S015
S014
S013 2011-01-14 30-day Notice
S012
S011 2009-10-13 30-day Notice
S010 2009-01-30 30-day Notice
S009 2008-08-18 Normal 180 Day Track No User Fee
S008 2008-08-18 Normal 180 Day Track No User Fee
S007 2008-08-13 30-day Notice
S006 2008-03-19 Normal 180 Day Track No User Fee
S005 2008-03-12 30-day Notice
S004 2007-08-29 Normal 180 Day Track No User Fee
S003 2007-02-26 Normal 180 Day Track No User Fee
S002 2007-02-23 Normal 180 Day Track
S001 2007-01-31 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
10888628002388 P020056 000
10888628002548 P020056 000
10888628002555 P020056 000
10888628002562 P020056 000
10888628002579 P020056 000
10888628002586 P020056 000
10888628002593 P020056 000
10888628002609 P020056 000
10888628001435 P020056 000
10888628001442 P020056 000
10888628001459 P020056 000
10888628001466 P020056 000
10888628001473 P020056 000
10888628001480 P020056 000
10888628002531 P020056 000
10888628002524 P020056 000
10888628002395 P020056 000
10888628002401 P020056 000
10888628002418 P020056 000
10888628002425 P020056 000
10888628002432 P020056 000
10888628002449 P020056 000
10888628002456 P020056 000
10888628002463 P020056 000
10888628002470 P020056 000
10888628002487 P020056 000
10888628002494 P020056 000
10888628002500 P020056 000
10888628002517 P020056 000
10888628001497 P020056 000
10888628001510 P020056 000
10888628001671 P020056 000
10888628001688 P020056 000
10888628001695 P020056 000
10888628001701 P020056 000
10888628001718 P020056 000
10888628001725 P020056 000
10888628001732 P020056 000
10888628001749 P020056 000
10888628001756 P020056 000
10888628001763 P020056 000
10888628001312 P020056 000
10888628001329 P020056 000
10888628001336 P020056 000
10888628001664 P020056 000
10888628001657 P020056 000
10888628001527 P020056 000
10888628001534 P020056 000
10888628001541 P020056 000
10888628001558 P020056 000
10888628001565 P020056 000
10888628001572 P020056 000
10888628001589 P020056 000
10888628001596 P020056 000
10888628001602 P020056 000
10888628001619 P020056 000
10888628001626 P020056 000
10888628001633 P020056 000
10888628001640 P020056 000
10888628001343 P020056 000
10888628001770 P020056 000
10888628001930 P020056 000
10888628001947 P020056 000
10888628001954 P020056 000
10888628001961 P020056 000
10888628001978 P020056 000
10888628001985 P020056 000
10888628001992 P020056 000
10888628002005 P020056 000
10888628002012 P020056 000
10888628002029 P020056 000
10888628002036 P020056 000
10888628002043 P020056 000
10888628002050 P020056 000
10888628001923 P020056 000
10888628001916 P020056 000
10888628001787 P020056 000
10888628001794 P020056 000
10888628001800 P020056 000
10888628001817 P020056 000
10888628001824 P020056 000
10888628001831 P020056 000
10888628001848 P020056 000
10888628001855 P020056 000
10888628001862 P020056 000
10888628001879 P020056 000
10888628001886 P020056 000
10888628001893 P020056 000
10888628001909 P020056 000
10888628002067 P020056 000
10888628002081 P020056 000
10888628002241 P020056 000
10888628002258 P020056 000
10888628002265 P020056 000
10888628002272 P020056 000
10888628002289 P020056 000
10888628002296 P020056 000
10888628002302 P020056 000
10888628002319 P020056 000
10888628002326 P020056 000
10888628002333 P020056 000
10888628002340 P020056 000
10888628002357 P020056 000
10888628002364 P020056 000
10888628002234 P020056 000
10888628002227 P020056 000
10888628002098 P020056 000
10888628002104 P020056 000
10888628002111 P020056 000
10888628002128 P020056 000
10888628002135 P020056 000
10888628002142 P020056 000
10888628002159 P020056 000
10888628002166 P020056 000
10888628002173 P020056 000
10888628002180 P020056 000
10888628002197 P020056 000
10888628002203 P020056 000
10888628002210 P020056 000
10888628002371 P020056 000
10888628001350 P020056 000
10888628002074 P020056 000
10888628001237 P020056 000
10888628001244 P020056 000
10888628001251 P020056 000
10888628001268 P020056 000
10888628001275 P020056 000
10888628001282 P020056 000
10888628001299 P020056 000
10888628001305 P020056 000
10888628001503 P020056 000
10888628001220 P020056 000
10888628001213 P020056 000
10888628001374 P020056 000
10888628001381 P020056 000
10888628001398 P020056 000
10888628001404 P020056 000
10888628001411 P020056 000
10888628001428 P020056 000
10888628001206 P020056 000
10888628001367 P020056 000
10888628001190 P020056 000
10888628001183 P020056 000
10888628008281 P020056 031
10888628008298 P020056 031
10888628008311 P020056 031
10888628008328 P020056 031
10888628008304 P020056 031
10888628008335 P020056 031
10888628008342 P020056 031
10888628008359 P020056 031
10888628008366 P020056 031
10888628008373 P020056 031
10888628008274 P020056 031
10888628008267 P020056 031
10888628008151 P020056 031
10888628008168 P020056 031
10888628008175 P020056 031
10888628008199 P020056 031
10888628008205 P020056 031
10888628008212 P020056 031
10888628008229 P020056 031
10888628008182 P020056 031
10888628008236 P020056 031
10888628008243 P020056 031
10888628008250 P020056 031
10888628008380 P020056 031
10888628008397 P020056 031
10888628008533 P020056 031
10888628008540 P020056 031
10888628008557 P020056 031
10888628008564 P020056 031
10888628008571 P020056 031
10888628008588 P020056 031
10888628008595 P020056 031
10888628008601 P020056 031
10888628008618 P020056 031
10888628008625 P020056 031
10888628008526 P020056 031
10888628008519 P020056 031
10888628008502 P020056 031
10888628008403 P020056 031
10888628008410 P020056 031
10888628008427 P020056 031
10888628008434 P020056 031
10888628008441 P020056 031
10888628008458 P020056 031
10888628008465 P020056 031
10888628008472 P020056 031
10888628008489 P020056 031
10888628008496 P020056 031
10888628008632 P020056 031
10888628008144 P020056 031
10888628007642 P020056 031
10888628007789 P020056 031
10888628007796 P020056 031
10888628007802 P020056 031
10888628007819 P020056 031
10888628007826 P020056 031
10888628007833 P020056 031
10888628007840 P020056 031
10888628007857 P020056 031
10888628007864 P020056 031
10888628007871 P020056 031
10888628007772 P020056 031
10888628007765 P020056 031
10888628007758 P020056 031
10888628007659 P020056 031
10888628007666 P020056 031
10888628007673 P020056 031
10888628007680 P020056 031
10888628007697 P020056 031
10888628007703 P020056 031
10888628007710 P020056 031
10888628007734 P020056 031
10888628007727 P020056 031
10888628007741 P020056 031
10888628007888 P020056 031
10888628007895 P020056 031
10888628008038 P020056 031
10888628008045 P020056 031
10888628008052 P020056 031
10888628008069 P020056 031
10888628008076 P020056 031
10888628008083 P020056 031
10888628008090 P020056 031
10888628008106 P020056 031
10888628008113 P020056 031
10888628008120 P020056 031
10888628008021 P020056 031
10888628008014 P020056 031
10888628008007 P020056 031
10888628007901 P020056 031
10888628007918 P020056 031
10888628007925 P020056 031
10888628007932 P020056 031
10888628007949 P020056 031
10888628007956 P020056 031
10888628007963 P020056 031
10888628007970 P020056 031
10888628007987 P020056 031
10888628007994 P020056 031
10888628008137 P020056 031

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.