PMA P000006S060
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S060
- Product code
- FHW
- Decision date
- 2021-12-22
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- New ethylene oxide sterilization process and chamber at the current sterilization provider, Steris AST.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S060
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2021-12-22
- Decision code
- OK30
- Date received
- 2021-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New ethylene oxide sterilization process and chamber at the current sterilization provider, Steris AST.