MENTOR MEMORYSHAPE BREAST IMPLANTS

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

FDA Premarket Approval P060028 S018

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 MEMORYSHAPE BREAST IMPLANTS
Classification NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantMENTOR WORLDWIDE LLC
Date Received2016-06-07
Decision Date2016-07-05
PMAP060028
SupplementS018
Product CodeFTR
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
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

Device IDPMASupp
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