MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Premarket Approval P990075

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 the mentor corporation saline-filled and spectrum mammary prostheses.

DeviceMENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
Classification NameProsthesis, Breast, Inflatable, Internal, Saline
Generic NameProsthesis, Breast, Inflatable, Internal, Saline
ApplicantMENTOR WORLDWIDE LLC
Date Received1999-11-12
Decision Date2000-05-10
Notice Date2001-01-18
PMAP990075
SupplementS
Product CodeFWM
Docket Number01M-0011
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
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P990075Original Filing
S054 2022-05-10 135 Review Track For 30-day Notice
S053
S052 2021-06-25 30-day Notice
S051
S050 2021-05-07 30-day Notice
S049 2020-10-30 30-day Notice
S048 2020-09-30 30-day Notice
S047 2020-09-28 30-day Notice
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 2003-08-01 30-day Notice
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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