PMA P000006S007

Device: COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S007
Product code: FHW
Decision date: 2008-06-13
Classification: Device, Impotence, Mechanical/hydraulic
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: APPROVAL FOR: 1) REVISION OF THE CURRENT TITAN PROSTHESIS TO INCLUDE A NEW ONE-TOUCH RELEASE PUMP BODY; 2) ADDITION OF NUSIL TECHNOLOGY MED-4755 SILICONE AS AN OPTIONAL ALTERNATIVE TO THE CURRENTLY USED NUSIL TECHNOLOGY MED-4515 AND MED-4750 SILICONES; 3) ADDITION OF A 1.5CM REAR TIP EXTENDER IN THE TITAN ASSEMBLY KITS; 4) ADDITION OF A SPECIFICATION IMPOSING A LOWER LIMIT OF 2.5 LB FOR TACTILE FORCE FOR DEFLATION USING THE OTR PUMP; AND 5) LABELING REVISIONS RELATING TO THE ABOVE DEVICE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TITAN OTR INFLATABLE PENILE PROSTHESIS 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: COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S007
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2008-06-13
Decision code: APPR
Date received: 2006-08-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) REVISION OF THE CURRENT TITAN PROSTHESIS TO INCLUDE A NEW ONE-TOUCH RELEASE PUMP BODY; 2) ADDITION OF NUSIL TECHNOLOGY MED-4755 SILICONE AS AN OPTIONAL ALTERNATIVE TO THE CURRENTLY USED NUSIL TECHNOLOGY MED-4515 AND MED-4750 SILICONES; 3) ADDITION OF A 1.5CM REAR TIP EXTENDER IN THE TITAN ASSEMBLY KITS; 4) ADDITION OF A SPECIFICATION IMPOSING A LOWER LIMIT OF 2.5 LB FOR TACTILE FORCE FOR DEFLATION USING THE OTR PUMP; AND 5) LABELING REVISIONS RELATING TO THE ABOVE DEVICE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TITAN OTR INFLATABLE PENILE PROSTHESIS AND IS INDICATED FOR MALE PATIENTS SUFFERING FROM ERECTILE DYSFUNCTION (IMPOTENCE) WHO ARE CONSIDERED TO BE CANDIDATES FOR IMPLANTATION OF A PENILE PROSTHESIS.