PMA P000006S075
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S075
- Product code
- FHW
- Decision date
- 2026-07-20
- Classification
- Gastroenterology, Urology
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- approval to incorporate a lot release strategy into the manufacturing process for the kink-resistant tubing
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S075
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2026-07-20
- Decision code
- OK30
- Date received
- 2026-06-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to incorporate a lot release strategy into the manufacturing process for the kink-resistant tubing