MENTOR MEMORYSHAPE BREAST IMPLANTS

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

FDA Premarket Approval P060028

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 thememoryshape breast implants. This device is indicated for females for the following uses(procedures):1) breast augmentation for women at least 22 years old. Breast augmentation includes primarybreast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. 2) breast reconstruction. Breast reconstruction includes primary reconstruction to replacebreast 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 revisionsurgery to correct or improve the results of a primary breast reconstruction surgery.

DeviceMENTOR MEMORYSHAPE BREAST IMPLANTS
Classification NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantMENTOR WORLDWIDE LLC
Date Received2006-10-02
Decision Date2013-06-14
Notice Date2013-06-19
PMAP060028
SupplementS
Product CodeFTR
Docket Number13M-0738
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address MENTOR WORLDWIDE LLC 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
P060028Original Filing
S044 2022-02-04 Normal 180 Day Track No User Fee
S043 2021-06-25 30-day Notice
S042
S041
S040 2021-05-07 30-day Notice
S039 2021-05-07 30-day Notice
S038
S037
S036 2020-09-28 30-day Notice
S035
S034 2019-10-23 30-day Notice
S033
S032
S031
S030
S029 2018-05-29 30-day Notice
S028
S027 2017-11-06 Special (immediate Track)
S026
S025 2017-06-06 Real-time Process
S024 2017-04-24 30-day Notice
S023 2017-03-27 30-day Notice
S022 2017-03-20 30-day Notice
S021 2017-03-14 30-day Notice
S020 2017-03-08 30-day Notice
S019 2016-11-22 135 Review Track For 30-day Notice
S018 2016-06-07 30-day Notice
S017
S016 2016-02-11 Normal 180 Day Track No User Fee
S015 2015-10-21 30-day Notice
S014 2015-09-30 135 Review Track For 30-day Notice
S013 2015-09-16 Normal 180 Day Track No User Fee
S012 2015-06-10 30-day Notice
S011 2015-04-08 30-day Notice
S010 2015-04-02 30-day Notice
S009
S008 2015-02-20 30-day Notice
S007 2015-02-20 30-day Notice
S006 2015-02-06 30-day Notice
S005 2014-12-22 Normal 180 Day Track
S004 2014-12-08 30-day Notice
S003 2014-11-25 30-day Notice
S002 2014-09-23 30-day Notice
S001 2014-03-26 Normal 180 Day Track

NIH GUDID Devices

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