MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Premarket Approval P990075 S037

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

Use of previously approved semi-automated primary packaging equipment spps following relocation from the main assembly controlled manufacturing environment cme room to the primary packaging cme room at the mentor irving, texas facility.

DeviceMENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
Classification NameProsthesis, Breast, Inflatable, Internal, Saline
Generic NameProsthesis, Breast, Inflatable, Internal, Saline
ApplicantMENTOR WORLDWIDE LLC
Date Received2016-06-07
Decision Date2016-07-05
PMAP990075
SupplementS037
Product CodeFWM
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MENTOR WORLDWIDE LLC 33 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P990075Original Filing
S054 2022-05-10 135 Review Track For 30-day Notice
S053
S052 2021-06-25 30-day Notice
S051
S050 2021-05-07 30-day Notice
S049 2020-10-30 30-day Notice
S048 2020-09-30 30-day Notice
S047 2020-09-28 30-day Notice
S046 2019-10-23 30-day Notice
S045 2019-06-25 30-day Notice
S044 2018-05-29 30-day Notice
S043 2017-11-06 Special (immediate Track)
S042 2017-07-12 30-day Notice
S041 2017-04-24 30-day Notice
S040 2017-03-27 30-day Notice
S039 2017-03-14 30-day Notice
S038 2017-03-08 30-day Notice
S037 2016-06-07 30-day Notice
S036 2016-03-17 30-day Notice
S035 2015-12-11 30-day Notice
S034 2015-10-21 30-day Notice
S033 2015-06-10 30-day Notice
S032 2015-04-02 30-day Notice
S031 2014-12-08 30-day Notice
S030 2014-11-25 30-day Notice
S029 2014-10-27 Real-time Process
S028 2014-10-22 30-day Notice
S027 2014-09-23 30-day Notice
S026 2014-07-15 30-day Notice
S025 2014-01-22 30-day Notice
S024 2013-07-31 30-day Notice
S023 2013-05-01 30-day Notice
S022 2011-02-11 Normal 180 Day Track No User Fee
S021 2008-04-02 Normal 180 Day Track No User Fee
S020
S019 2008-01-24 Normal 180 Day Track
S018
S017 2007-03-01 30-day Notice
S016 2005-06-27 Real-time Process
S015 2004-08-24 Normal 180 Day Track
S014 2003-11-20 Normal 180 Day Track No User Fee
S013 2003-08-01 30-day Notice
S012 2003-07-16 30-day Notice
S011 2003-02-24 30-day Notice
S010 2003-02-07 30-day Notice
S009 2002-07-01 Normal 180 Day Track
S008 2002-05-10 30-day Notice
S007 2002-03-26 30-day Notice
S006 2001-07-26 Normal 180 Day Track
S005 2001-07-09 Normal 180 Day Track
S004 2001-07-10 Normal 180 Day Track
S003 2001-05-14 Normal 180 Day Track
S002 2000-10-23 Normal 180 Day Track
S001 2000-06-08 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00081317001713 P990075 000
00081317001850 P990075 000
00081317001867 P990075 000
00081317001874 P990075 000
00081317001881 P990075 000
00081317001904 P990075 000
00081317001911 P990075 000
00081317001928 P990075 000
00081317001935 P990075 000
00081317001942 P990075 000
00081317001843 P990075 000
00081317001836 P990075 000
00081317001829 P990075 000
00081317001720 P990075 000
00081317001737 P990075 000
00081317001751 P990075 000
00081317001768 P990075 000
00081317001775 P990075 000
00081317001782 P990075 000
00081317001799 P990075 000
00081317001805 P990075 000
00081317001812 P990075 000
00081317001744 P990075 000
00081317001256 P990075 000
00081317001270 P990075 000
00081317001300 P990075 000
00081317001263 P990075 000
00081317004561 P990075 000
00081317001249 P990075 000
00081317001232 P990075 000
00081317001225 P990075 000
00081317001218 P990075 000
00081317001201 P990075 000
00081317001195 P990075 000
00081317001294 P990075 000
00081317001317 P990075 000
00081317009054 P990075 000
00081317009047 P990075 000
00081317001898 P990075 000
00081317009030 P990075 000
00081317001171 P990075 000
00081317001331 P990075 000
00081317001324 P990075 000
00081317001188 P990075 000
00081317001638 P990075 003
00081317001645 P990075 003
00081317001652 P990075 003
00081317001591 P990075 003
00081317001577 P990075 003
00081317001560 P990075 003
00081317001584 P990075 003
00081317001621 P990075 003
00081317001614 P990075 003
00081317001607 P990075 003
00081317001669 P990075 003
00081317001676 P990075 003
00081317001683 P990075 003
00081317001690 P990075 003
00081317001706 P990075 003
00081317001461 P990075 016
00081317001454 P990075 016
00081317001447 P990075 016
00081317001423 P990075 016
00081317001416 P990075 016
00081317001409 P990075 016
00081317001393 P990075 016
00081317001386 P990075 016
00081317001379 P990075 016
00081317001362 P990075 016
00081317001355 P990075 016
00081317001348 P990075 016
00081317001430 P990075 016
00081317001478 P990075 016
00081317001485 P990075 016
00081317001539 P990075 016
00081317001522 P990075 016
00081317001515 P990075 016
00081317001508 P990075 016
00081317001492 P990075 016
00081317002086 P990075 019
00081317002116 P990075 019
00081317002123 P990075 019
00081317002109 P990075 019
00081317002130 P990075 019
00081317002147 P990075 019
00081317002154 P990075 019
00081317002161 P990075 019
00081317002178 P990075 019
00081317004059 P990075 019
00081317001959 P990075 019
00081317002093 P990075 019
00081317002062 P990075 019
00081317002031 P990075 019
00081317001980 P990075 019
00081317002024 P990075 019
00081317002017 P990075 019
00081317002000 P990075 019
00081317001997 P990075 019
00081317001973 P990075 019
00081317001966 P990075 019
00081317002048 P990075 019
00081317002055 P990075 019
00081317002079 P990075 019
00081317001287 P990075 022

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