Saline-Filled and Spectrum Breast Implants

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Premarket Approval P990075 S046

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 saline-filled and spectrum breast implants.

DeviceSaline-Filled and Spectrum Breast Implants
Classification NameProsthesis, Breast, Inflatable, Internal, Saline
Generic NameProsthesis, Breast, Inflatable, Internal, Saline
ApplicantMENTOR WORLDWIDE LLC
Date Received2019-10-23
Decision Date2019-11-19
PMAP990075
SupplementS046
Product CodeFWM
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
P990075Original Filing
S046 2019-10-23 30-day Notice
S045 2019-06-25 30-day Notice
S044 2018-05-29 30-day Notice
S043 2017-11-06 Special (immediate Track)
S042 2017-07-12 30-day Notice
S041 2017-04-24 30-day Notice
S040 2017-03-27 30-day Notice
S039 2017-03-14 30-day Notice
S038 2017-03-08 30-day Notice
S037 2016-06-07 30-day Notice
S036 2016-03-17 30-day Notice
S035 2015-12-11 30-day Notice
S034 2015-10-21 30-day Notice
S033 2015-06-10 30-day Notice
S032 2015-04-02 30-day Notice
S031 2014-12-08 30-day Notice
S030 2014-11-25 30-day Notice
S029 2014-10-27 Real-time Process
S028 2014-10-22 30-day Notice
S027 2014-09-23 30-day Notice
S026 2014-07-15 30-day Notice
S025 2014-01-22 30-day Notice
S024 2013-07-31 30-day Notice
S023 2013-05-01 30-day Notice
S022 2011-02-11 Normal 180 Day Track No User Fee
S021 2008-04-02 Normal 180 Day Track No User Fee
S020
S019 2008-01-24 Normal 180 Day Track
S018
S017 2007-03-01 30-day Notice
S016 2005-06-27 Real-time Process
S015 2004-08-24 Normal 180 Day Track
S014 2003-11-20 Normal 180 Day Track No User Fee
S013
S012 2003-07-16 30-day Notice
S011 2003-02-24 30-day Notice
S010 2003-02-07 30-day Notice
S009 2002-07-01 Normal 180 Day Track
S008 2002-05-10 30-day Notice
S007 2002-03-26 30-day Notice
S006 2001-07-26 Normal 180 Day Track
S005 2001-07-09 Normal 180 Day Track
S004 2001-07-10 Normal 180 Day Track
S003 2001-05-14 Normal 180 Day Track
S002 2000-10-23 Normal 180 Day Track
S001 2000-06-08 Normal 180 Day Track

NIH GUDID Devices

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