PMA P000006S054
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- Product code
- FHW
- Decision date
- 2020-07-10
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- Approval for changing the silicone material used in the components of Titan Penile Prosthesis.
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S054
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2020-07-10
- Decision code
- APPR
- Date received
- 2019-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changing the silicone material used in the components of Titan Penile Prosthesis.