Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
• Generic Name: Device, impotence, mechanical/hydraulic
• Regulation Number: 876.3350
• Applicant: COLOPLAST CORP.; 1601 WEST RIVER ROAD NORTH; MINNEAPOLIS, MN 55411
• PMA Number: P000006
• Supplement Number: S007
• Date Received: 08/16/2006
• Decision Date: 06/13/2008
• Product Code: FHW
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

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.