MENTOR SALINE-FILLED TESTICULAR PROSTHESIS

Prosthesis, Testicular

FDA Premarket Approval P020003 S002

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

Change involving the engraving process, a change in a raw material supplier and a minor change in the molding process.

• Device: MENTOR SALINE-FILLED TESTICULAR PROSTHESIS
• Classification Name: Prosthesis, Testicular
• Generic Name: Prosthesis, Testicular
• Applicant: COLOPLAST CORP.
• Date Received: 2004-02-17
• Decision Date: 2004-03-18
• PMA: P020003
• Supplement: S002
• Product Code: FAF
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: COLOPLAST CORP. 1601 West River Road North minneapolis, MN 55411

Supplemental Filings

Supplement Number	Date	Supplement Type
P020003		Original 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 ID	PMA	Supp
05708932470858	P020003	007
05708932470834	P020003	007
05708932470810	P020003	007
05708932470797	P020003	007