PMA P000006S005
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S005
- Product code
- FHW
- Decision date
- 2005-01-12
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ADAPTER TO THE REAR TIP EXTENDERS INCLUDED IN THE ASSEMBLY KIT.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S005
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2005-01-12
- Decision code
- APPR
- Date received
- 2004-12-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ADAPTER TO THE REAR TIP EXTENDERS INCLUDED IN THE ASSEMBLY KIT.