NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled

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

FDA Premarket Approval P040046 S023

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

Implement an electronic data acquisition (eda) system for the shell assembly vulcanization process to collect and store temperature, pressure, and time data. The above change is located 900 parkway global park, la aurora, heredia, costa rica.

DeviceNATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled
Classification NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantAllergan
Date Received2017-06-07
Decision Date2017-07-05
PMAP040046
SupplementS023
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
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

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