PMA P000006S037

Device: TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S037
Product code: FHW
Decision date: 2014-08-13
Classification: Device, Impotence, Mechanical/hydraulic
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: APPROVAL FOR REVISIONS IN THE TITAN INSTRUCTIONS FOR USE TO HAVE PATIENTS WITH A DOCUMENTED SENSITIVITY TO SILICONE AS A CONTRAINDICATION INSTEAD OF BEING LISTED AS A WARNING.

Current openFDA PMA Record#

Device: TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S037
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2014-08-13
Decision code: APPR
Date received: 2014-08-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISIONS IN THE TITAN INSTRUCTIONS FOR USE TO HAVE PATIENTS WITH A DOCUMENTED SENSITIVITY TO SILICONE AS A CONTRAINDICATION INSTEAD OF BEING LISTED AS A WARNING.