PMA P000006S012
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S012
- Product code
- FHW
- Decision date
- 2008-12-19
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR THREE LARGER CYLINDER SIZES (I.E., LENGTHS OF 24, 26, AND28 CM), AND RELATED CHANGES FOR LARGER PACKAGING, A MODIFICATION TO THE CYLINDER MANUFACTURINGPROCESS, ADDITIONAL LABELS FOR THE LARGER CYLINDER SIZES, REVISED INSTRUCTIONS FOR USE TO INCLUDE ADDITIONAL CATALOG NUMBERS FOR THE NEW CYLINDER SIZES, AND A NEW LABELING STATEMENT THAT RECOMMENDS USE OF THE L00CC RESERVOIR WITH THE NEW LARGER CYLINDER SIZES.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S012
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2008-12-19
- Decision code
- APPR
- Date received
- 2008-10-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THREE LARGER CYLINDER SIZES (I.E., LENGTHS OF 24, 26, AND28 CM), AND RELATED CHANGES FOR LARGER PACKAGING, A MODIFICATION TO THE CYLINDER MANUFACTURINGPROCESS, ADDITIONAL LABELS FOR THE LARGER CYLINDER SIZES, REVISED INSTRUCTIONS FOR USE TO INCLUDE ADDITIONAL CATALOG NUMBERS FOR THE NEW CYLINDER SIZES, AND A NEW LABELING STATEMENT THAT RECOMMENDS USE OF THE L00CC RESERVOIR WITH THE NEW LARGER CYLINDER SIZES.