PMA P000006S024
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S024
- Product code
- FHW
- Decision date
- 2012-02-13
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR 1) A CHANGE IN THE ANGLE OF THE TUBING ON THE CYLINDER FROM THE CURRENT 45 DEGREES TO 0 DEGREES ANGLE TO IMPROVE THE EASE OF IMPLANTATION; AND 2) TO CHANGE THE TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S024
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2012-02-13
- Decision code
- APPR
- Date received
- 2011-05-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 1) A CHANGE IN THE ANGLE OF THE TUBING ON THE CYLINDER FROM THE CURRENT 45 DEGREES TO 0 DEGREES ANGLE TO IMPROVE THE EASE OF IMPLANTATION; AND 2) TO CHANGE THE TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750.