MemoryGel Silicone Gel-Filled Breast Implants

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

FDA Premarket Approval P030053 S054

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 memorygel silicone gel-filled breast implants.

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 Received2019-10-23
Decision Date2019-11-19
PMAP030053
SupplementS054
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 CORP. 33 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P030053Original Filing
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

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