PMA P000006S071
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S071
- Product code
- FHW
- Decision date
- 2025-08-14
- Classification
- Gastroenterology, Urology
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- approval for modifications to the True Lock components in the Titan Assembly Kit and True Lock Plug, and a new pouch sealer.
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S071
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2025-08-14
- Decision code
- APPR
- Date received
- 2025-05-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for modifications to the True Lock components in the Titan Assembly Kit and True Lock Plug, and a new pouch sealer.