PMA P000006S002

Device: MENTOR TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S002
Product code: FHW
Decision date: 2003-01-14
Classification: Device, Impotence, Mechanical/hydraulic
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: APPROVAL FOR REPROCESSING FINAL, STERILIZED ALPHA I INFLATABLE PENILE PROSTHESES TO INCORPORATE THE HYDROPHILIC COATING THAT WAS PREVIOUSLY APPROVED FOR USE ON NEWLY MANUFACTURED PROSTHESES IN SUPPLEMENT 1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR TITAN INFLATABLE PENILE PROSTHESIS AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.

Current openFDA PMA Record#

Device: MENTOR TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S002
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2003-01-14
Decision code: APPR
Date received: 2002-08-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR REPROCESSING FINAL, STERILIZED ALPHA I INFLATABLE PENILE PROSTHESES TO INCORPORATE THE HYDROPHILIC COATING THAT WAS PREVIOUSLY APPROVED FOR USE ON NEWLY MANUFACTURED PROSTHESES IN SUPPLEMENT 1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR TITAN INFLATABLE PENILE PROSTHESIS AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.