COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA Premarket Approval P020003

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 saline-filled testicular prosthesis. The device is indicated for use when cosmetic testicular replacement is indicated; i. E. , in the case of agenesis or following the surgical removal of a testicle.

DeviceCOLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
Classification NameProsthesis, Testicular
Generic NameProsthesis, Testicular
ApplicantCOLOPLAST CORP.
Date Received2002-01-22
Decision Date2002-07-19
Notice Date2002-08-06
PMAP020003
SupplementS
Product CodeFAF
Docket Number02M-0322
Advisory CommitteeGastroenterology/Urology
Expedited ReviewYes
Combination Product No
Applicant Address COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

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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