MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS

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

FDA Premarket Approval P030053

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the mentor memorygel silicone gel-filled breast implants. This device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

DeviceMEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
Classification NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantMENTOR CORP.
Date Received2003-12-12
Decision Date2006-11-17
Notice Date2006-11-17
PMAP030053
SupplementS
Product CodeFTR
Docket Number06M-0492
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address MENTOR CORP. 33 Technology Drive irvine, CA 92618
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P030053Original Filing
S064 2021-06-25 30-day Notice
S063
S062
S061 2021-05-07 30-day Notice
S060 2021-05-07 30-day Notice
S059
S058
S057
S056 2020-09-29 Real-time Process
S055 2020-09-28 30-day Notice
S054 2019-10-23 30-day Notice
S053
S052 2019-06-12 30-day Notice
S051
S050
S049
S048
S047 2018-05-29 30-day Notice
S046
S045 2018-01-08 30-day Notice
S044 2017-11-06 Special (immediate Track)
S043 2017-07-13 Real-time Process
S042 2017-04-24 30-day Notice
S041 2017-03-27 30-day Notice
S040 2017-03-20 30-day Notice
S039 2017-03-14 30-day Notice
S038 2017-03-08 30-day Notice
S037 2017-02-14 Real-time Process
S036 2016-11-22 135 Review Track For 30-day Notice
S035 2016-06-07 30-day Notice
S034 2016-05-27 30-day Notice
S033 2016-03-17 30-day Notice
S032 2015-10-21 30-day Notice
S031 2015-09-16 Normal 180 Day Track No User Fee
S030 2015-08-26 30-day Notice
S029 2015-06-10 30-day Notice
S028 2015-04-08 30-day Notice
S027 2015-04-02 30-day Notice
S026 2015-03-19 30-day Notice
S025
S024 2015-02-20 30-day Notice
S023 2014-12-16 30-day Notice
S022 2014-12-08 30-day Notice
S021 2014-11-25 30-day Notice
S020 2014-09-23 30-day Notice
S019 2014-08-04 Normal 180 Day Track No User Fee
S018 2014-07-02 30-day Notice
S017 2014-02-19 Normal 180 Day Track No User Fee
S016 2013-12-18 Real-time Process
S015
S014 2013-04-10 Normal 180 Day Track No User Fee
S013 2013-01-25 Real-time Process
S012 2011-02-11 Normal 180 Day Track No User Fee
S011 2011-01-19 Normal 180 Day Track No User Fee
S010
S009 2010-07-16 Normal 180 Day Track No User Fee
S008 2009-09-28 Normal 180 Day Track No User Fee
S007
S006 2008-04-29 Normal 180 Day Track No User Fee
S005 2007-05-31 Normal 180 Day Track
S004 2007-03-27 Normal 180 Day Track No User Fee
S003
S002 2006-12-20 Normal 180 Day Track
S001 2006-12-14 Normal 180 Day Track No User Fee

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