Titan Inflatable Penile Prosthesis (IPP)

FDA Premarket Approval P000006 S056

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

To add a fixture to the standard cylinder bladder tip cutting manufacturing process for the titan inflatable penile prosthesis

DeviceTitan Inflatable Penile Prosthesis (IPP)
Generic NameDevice, Impotence, Mechanical/hydraulic
ApplicantCOLOPLAST CORP.
Date Received2020-05-08
Decision Date2020-06-05
PMAP000006
SupplementS056
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
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

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