NATRELLE Saline-Filled Breast Implants

FDA Premarket Approval P990074 S050

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

DeviceNATRELLE Saline-Filled Breast Implants
Generic NameProsthesis, Breast, Inflatable, Internal, Saline
ApplicantAllergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP990074 Supplement NumberS050 Date Received04/04/2022 Decision Date12/29/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-04-04
Decision Date2022-12-29
PMAP990074
SupplementS050
Product CodeFWM 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressAllergan
2525 Dupont Dr.
irvine, CA 92612 PMA NumberP990074 Supplement NumberS050 Date Received04/04/2022 Decision Date12/29/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Modifications To Physician And Patient Labeling.

Supplemental Filings

Supplement NumberDateSupplement Type
P990074Original Filing
S050 2022-04-04 Real-time Process
S049 2022-04-01 135 Review Track For 30-day Notice
S048 2021-06-30 30-day Notice
S047 2021-06-21 30-day Notice
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

NIH GUDID Devices

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