PMA P000006S072
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S072
- Product code
- FHW
- Decision date
- 2026-06-02
- Classification
- Gastroenterology, Urology
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- Approval for design and packaging changes
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S072
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2026-06-02
- Decision code
- APPR
- Date received
- 2025-10-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for design and packaging changes