- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S074
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2026-07-21
- Decision code
- OK30
- Date received
- 2026-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to increase the amount of manufacturing cleanroom space by converting existing space into a new cleanroom, along with installing a deionized water system and clean dry air system in the cleanroom