MemoryShape Silicone Gel-Filled Breast Implants

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

FDA Premarket Approval P060028 S034

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

Qualification of new manufacturing equipment related to the removal of foreign debris from packaging used for memoreshape silicone gel-filled breast implants.

DeviceMemoryShape Silicone Gel-Filled Breast Implants
Classification NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic NameProsthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
ApplicantMENTOR WORLDWIDE LLC
Date Received2019-10-23
Decision Date2019-11-19
PMAP060028
SupplementS034
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
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
S010 2015-04-02 30-day Notice
S009
S008
S007 2015-02-20 30-day Notice
S006 2015-02-06 30-day Notice
S005
S004
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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