PMA P000006S076
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S076
- Product code
- FHW
- Decision date
- 2026-08-13
- Classification
- Gastroenterology, Urology
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- implements a non-destructive in-process test method for measuring Bioflex coating thickness on kink resistant tubing
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S076
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2026-08-13
- Decision code
- OK30
- Date received
- 2026-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implements a non-destructive in-process test method for measuring Bioflex coating thickness on kink resistant tubing