Titan Inflatable Penile Prosthesis

FDA premarket approval P000006 · Device, impotence, mechanical/hydraulic

PMA numberP000006

Approval

Applicant
Coloplast Corp.
Received
January 18, 2000
Decision date
July 14, 2000 (APPR)
Supplements
69, latest August 13, 2026
Product code
FHW – Device, Impotence, Mechanical/Hydraulic

Official FDA PMA record

Approval order statement

APPROVAL FOR THE MENTOR ALPHA I INFLATABLE PENILE PROSTHESIS. THIS DEVICE IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.