NATRELLE Silicone-Filled Breast Implants

FDA Premarket Approval P990074 S046

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

Change to implement an electronic data acquisition (eda) system to record and store the cycle parameters of the dry heat sterilization process used in the manufacture of allergan natrelle® saline-filled breast implants and allergan natrelle® silicone-filled breast implants

DeviceNATRELLE Silicone-Filled Breast Implants
Generic NameProsthesis, Breast, Inflatable, Internal, Saline
ApplicantAllergan
Date Received2021-05-26
Decision Date2021-06-25
PMAP990074
SupplementS046
Product CodeFWM 
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
P990074Original Filing
S046 2021-05-26 30-day Notice
S045
S044 2020-06-30 30-day Notice
S043 2019-11-04 30-day Notice
S042 2018-07-02 30-day Notice
S041 2017-10-02 30-day Notice
S040 2017-07-20 30-day Notice
S039 2017-06-07 30-day Notice
S038 2017-04-13 135 Review Track For 30-day Notice
S037 2017-03-01 Normal 180 Day Track
S036 2016-11-23 Real-time Process
S035 2016-11-07 30-day Notice
S034 2016-09-30 30-day Notice
S033 2016-09-07 Special (immediate Track)
S032 2014-09-29 30-day Notice
S031 2014-09-15 Normal 180 Day Track
S030 2014-08-06 Real-time Process
S029 2014-05-30 Normal 180 Day Track No User Fee
S028 2013-12-31 Real-time Process
S027 2013-06-12 30-day Notice
S026 2013-05-20 30-day Notice
S025 2013-02-26 30-day Notice
S024 2012-05-30 30-day Notice
S023 2011-01-24 Normal 180 Day Track No User Fee
S022 2009-10-13 30-day Notice
S021 2009-01-30 30-day Notice
S020 2008-09-04 Normal 180 Day Track No User Fee
S019 2008-08-19 30-day Notice
S018 2007-02-23 Normal 180 Day Track No User Fee
S017 2006-10-03 Normal 180 Day Track No User Fee
S016 2004-10-25 Normal 180 Day Track No User Fee
S015 2003-06-05 Normal 180 Day Track No User Fee
S014 2003-02-13 Normal 180 Day Track
S013 2002-08-09 Normal 180 Day Track
S012 2002-07-23 Normal 180 Day Track
S011 2002-06-17 Normal 180 Day Track
S010 2001-11-14 30-day Notice
S009 2001-08-31 Special (immediate Track)
S008 2001-07-23 30-day Notice
S007 2001-06-11 30-day Notice
S006 2001-04-17 Normal 180 Day Track
S005 2001-01-29 Normal 180 Day Track
S004 2000-12-18 Normal 180 Day Track
S003 2000-11-29 30-day Notice
S002 2000-06-09 Normal 180 Day Track
S001 2000-08-28 Normal 180 Day Track

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