PMA P000006S022
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S022
- Product code
- FHW
- Decision date
- 2011-01-24
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE RESERVOIR COMPONENT (I.E., THE CLOVERLEAF (CL) RESERVOIR) AND ASSOCIATED LABELING CHANGES.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S022
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2011-01-24
- Decision code
- APPR
- Date received
- 2010-12-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE RESERVOIR COMPONENT (I.E., THE CLOVERLEAF (CL) RESERVOIR) AND ASSOCIATED LABELING CHANGES.