NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled

FDA Premarket Approval P040046 S022

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

Approval of a planned manufacturing capacity expansion at the costa rica manufacturing facility and the addition of manufacturing equipment.

DeviceNATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
Classification NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantAllergan
Date Received2017-04-13
Decision Date2017-10-13
PMAP040046
SupplementS022
Product CodeFTR
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type135 Review Track For 30-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
P040046Original Filing
S032 2020-06-30 30-day Notice
S031
S030 2019-06-06 30-day Notice
S029 2018-07-02 30-day Notice
S028
S027 2017-12-18 135 Review Track For 30-day Notice
S026 2017-10-02 30-day Notice
S025 2017-07-20 30-day Notice
S024 2017-07-03 30-day Notice
S023 2017-06-07 30-day Notice
S022 2017-04-13 135 Review Track For 30-day Notice
S021 2017-03-01 Normal 180 Day Track
S020
S019 2016-11-23 Real-time Process
S018 2016-11-07 30-day Notice
S017 2016-09-07 Special (immediate Track)
S016 2016-05-24 Real-time Process
S015 2016-05-17 30-day Notice
S014 2015-12-30 Normal 180 Day Track No User Fee
S013 2014-12-30 Normal 180 Day Track
S012 2014-10-16 Normal 180 Day Track No User Fee
S011 2014-09-29 30-day Notice
S010
S009 2014-09-15 Normal 180 Day Track
S008 2014-08-11 Real-time Process
S007 2014-05-30 Normal 180 Day Track No User Fee
S006 2014-01-17 30-day Notice
S005 2014-01-02 Normal 180 Day Track No User Fee
S004 2013-06-12 30-day Notice
S003 2013-05-22 30-day Notice
S002 2013-05-20 30-day Notice
S001 2013-02-26 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10888628003590 P040046 000
10888628003316 P040046 000
10888628003309 P040046 000
10888628003293 P040046 000
10888628003286 P040046 000
10888628003279 P040046 000
10888628003262 P040046 000
10888628003255 P040046 000
10888628003248 P040046 000
10888628003231 P040046 000
10888628003224 P040046 000
10888628003217 P040046 000
10888628003200 P040046 000
10888628003323 P040046 000
10888628003460 P040046 000
10888628003583 P040046 000
10888628003576 P040046 000
10888628003569 P040046 000
10888628003552 P040046 000
10888628003545 P040046 000
10888628003538 P040046 000
10888628003521 P040046 000
10888628003514 P040046 000
10888628003507 P040046 000
10888628003491 P040046 000
10888628003484 P040046 000
10888628003477 P040046 000
10888628003194 P040046 000
10888628003187 P040046 000
10888628003170 P040046 000
10888628003026 P040046 000
10888628003019 P040046 000
10888628003002 P040046 000
10888628002982 P040046 000
10888628002975 P040046 000
10888628002968 P040046 000
10888628002951 P040046 000
10888628002944 P040046 000
10888628002937 P040046 000
10888628002920 P040046 000
10888628003392 P040046 000
10888628003385 P040046 000
10888628003033 P040046 000
10888628003040 P040046 000
10888628003163 P040046 000
10888628003156 P040046 000
10888628003149 P040046 000
10888628003132 P040046 000
10888628003125 P040046 000
10888628003118 P040046 000
10888628003101 P040046 000
10888628003095 P040046 000
10888628003088 P040046 000
10888628003071 P040046 000
10888628003064 P040046 000
10888628003057 P040046 000
10888628003378 P040046 000
10888628003606 P040046 000
10888628002678 P040046 000
10888628002821 P040046 000
10888628002814 P040046 000
10888628002784 P040046 000
10888628002777 P040046 000
10888628002760 P040046 000
10888628002753 P040046 000
10888628002746 P040046 000
10888628002739 P040046 000
10888628002722 P040046 000
10888628002715 P040046 000
10888628002708 P040046 000
10888628002692 P040046 000
10888628002838 P040046 000
10888628002845 P040046 000
10888628002661 P040046 000
10888628002654 P040046 000
10888628002647 P040046 000
10888628002630 P040046 000
10888628002623 P040046 000
10888628002913 P040046 000
10888628002906 P040046 000
10888628002890 P040046 000
10888628002883 P040046 000
10888628002876 P040046 000
10888628002869 P040046 000
10888628002852 P040046 000
10888628002685 P040046 000
10888628003453 P040046 000
10888628003446 P040046 000
10888628003743 P040046 000
10888628003736 P040046 000
10888628003729 P040046 000
10888628003712 P040046 000
10888628003705 P040046 000
10888628003699 P040046 000
10888628003682 P040046 000
10888628003675 P040046 000
10888628003668 P040046 000
10888628003651 P040046 000
10888628003644 P040046 000
10888628003637 P040046 000
10888628003750 P040046 000
10888628003767 P040046 000
10888628003439 P040046 000
10888628003422 P040046 000
10888628003415 P040046 000
10888628003408 P040046 000
10888628003354 P040046 000
10888628003347 P040046 000
10888628003330 P040046 000
10888628003620 P040046 000
10888628002999 P040046 000
10888628003798 P040046 000
10888628003781 P040046 000
10888628003774 P040046 000
10888628003613 P040046 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.