Coloplast Saline-Filled Testicular Prosthesis (Torosa)

FDA Premarket Approval P020003 S011

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

DeviceColoplast Saline-Filled Testicular Prosthesis (Torosa)
Generic NameProsthesis, Testicular
ApplicantCOLOPLAST CORP.1601 West River Road Northminneapolis, MN 55411 PMA NumberP020003 Supplement NumberS011 Date Received08/17/2022 Decision Date09/16/2022 Product Code FAF  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-17
Decision Date2022-09-16
PMAP020003
SupplementS011
Product CodeFAF 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCOLOPLAST CORP.
1601 West River Road North
minneapolis, MN 55411 PMA NumberP020003 Supplement NumberS011 Date Received08/17/2022 Decision Date09/16/2022 Product Code FAF  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementation Of A Size Inspection Step For The Torosa Saline Filled Testicular Prosthesis (SFTP) During Manufacturing

Supplemental Filings

Supplement NumberDateSupplement Type
P020003Original Filing
S011 2022-08-17 30-day Notice
S010 2022-07-27 30-day Notice
S009 2019-09-27 30-day Notice
S008 2018-08-06 30-day Notice
S007 2010-08-18 Normal 180 Day Track No User Fee
S006 2008-11-24 30-day Notice
S005 2007-07-23 Normal 180 Day Track No User Fee
S004 2006-05-18 135 Review Track For 30-day Notice
S003 2004-07-13 Special (immediate Track)
S002 2004-02-17 30-day Notice
S001 2002-11-07 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05708932470858 P020003 007
05708932470834 P020003 007
05708932470810 P020003 007
05708932470797 P020003 007

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