Coloplast Saline-Filled Testicular Prosthesis

FDA premarket approval P020003 · Prosthesis, testicular

PMA numberP020003

Approval

Applicant
Coloplast Corp.
Received
January 22, 2002
Decision date
July 19, 2002 (APPR)
Supplements
12, latest July 21, 2026
Product code
FAF – Prosthesis, Testicular

Official FDA PMA record

Approval order statement

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.