TITAN INFLATABLE PENILE PROSTHESIS

Device, Impotence, Mechanical/hydraulic

FDA Premarket Approval P000006 S043

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

Implementing an update to a drawing.

DeviceTITAN INFLATABLE PENILE PROSTHESIS
Classification NameDevice, Impotence, Mechanical/hydraulic
Generic NameDevice, Impotence, Mechanical/hydraulic
ApplicantCOLOPLAST CORP.
Date Received2015-02-03
Decision Date2015-03-05
PMAP000006
SupplementS043
Product CodeFHW
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411

Supplemental Filings

Supplement NumberDateSupplement Type
P000006Original Filing
S065 2022-12-16 30-day Notice
S064
S063 2022-11-02 30-day Notice
S062 2022-07-27 30-day Notice
S061 2022-03-16 30-day Notice
S060 2021-11-26 30-day Notice
S059 2020-12-09 30-day Notice
S058 2020-09-08 Real-time Process
S057 2020-09-01 30-day Notice
S056 2020-05-08 30-day Notice
S055
S054
S053 2019-09-27 30-day Notice
S052 2019-07-22 30-day Notice
S051
S050 2018-08-06 30-day Notice
S049 2018-06-27 30-day Notice
S048
S047 2017-06-08 Real-time Process
S046 2017-02-22 Real-time Process
S045 2015-09-21 Real-time Process
S044 2015-02-12 Special (immediate Track)
S043 2015-02-03 30-day Notice
S042 2015-02-02 30-day Notice
S041 2015-02-02 30-day Notice
S040 2015-01-27 Normal 180 Day Track
S039 2014-12-09 30-day Notice
S038 2014-10-15 Special (immediate Track)
S037 2014-08-01 Special (immediate Track)
S036 2014-02-14 135 Review Track For 30-day Notice
S035 2013-12-20 30-day Notice
S034 2013-10-23 Normal 180 Day Track
S033 2013-04-01 Real-time Process
S032 2013-01-22 30-day Notice
S031 2013-01-18 30-day Notice
S030 2013-01-08 Real-time Process
S029 2012-12-14 Real-time Process
S028 2012-03-26 30-day Notice
S027 2011-09-26 Real-time Process
S026 2011-08-29 30-day Notice
S025 2011-07-22 30-day Notice
S024 2011-05-02 Real-time Process
S023 2011-04-26 30-day Notice
S022 2010-12-02 Real-time Process
S021 2010-06-14 30-day Notice
S020
S019 2010-04-06 30-day Notice
S018 2009-12-22 30-day Notice
S017 2010-01-19 Real-time Process
S016
S015 2009-08-14 30-day Notice
S014 2008-12-12 135 Review Track For 30-day Notice
S013 2008-11-24 30-day Notice
S012 2008-10-17 Real-time Process
S011 2008-08-19 Real-time Process
S010 2008-04-25 Normal 180 Day Track No User Fee
S009 2008-03-11 Real-time Process
S008
S007 2006-08-16 Normal 180 Day Track
S006
S005 2004-12-30 Real-time Process
S004 2004-04-01 30-day Notice
S003 2002-10-17 Normal 180 Day Track
S002 2002-08-07 Normal 180 Day Track
S001 2001-05-17 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05708932319621 P000006 001
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05708932661416 P000006 046
05708932072519 P000006 047
05708932072526 P000006 047
05708932072557 P000006 047
05708932072564 P000006 047
05708932072595 P000006 047
05708932072601 P000006 047
05708932072632 P000006 047
05708932072649 P000006 047
05701780277006 P000006 064
05701780276979 P000006 064

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