PMA P000006S029
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S029
- Product code
- FHW
- Decision date
- 2013-01-29
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE TITAN NARROW BASECYLINDER (11 AND 14 CM LENGTHS ONLY): (I) CHANGE OF THE ANGLE OF THE TUBING FROM 22.5° TO 0°, AND (II) CHANGE IN CYLINDER 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
- S029
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2013-01-29
- Decision code
- APPR
- Date received
- 2012-12-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE TITAN NARROW BASECYLINDER (11 AND 14 CM LENGTHS ONLY): (I) CHANGE OF THE ANGLE OF THE TUBING FROM 22.5° TO 0°, AND (II) CHANGE IN CYLINDER TIP MATERIAL FROM DIPPED-ON BIOFLEX TO BONDED-ON MED 4750.