PMA P000006S001

Device: ALPHA I INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S001
Product code: FHW
Decision date: 2002-06-14
Classification: Device, Impotence, Mechanical/hydraulic
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: APPROVAL FOR HYDROPHILIC COATING OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR ALPHA 1 INFLATABLE PENILE PROSTHESIS WITH HYDROPHILIC COATING AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.

Current openFDA PMA Record#

Device: ALPHA I INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S001
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2002-06-14
Decision code: APPR
Date received: 2001-05-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR HYDROPHILIC COATING OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MENTOR ALPHA 1 INFLATABLE PENILE PROSTHESIS WITH HYDROPHILIC COATING AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.