PMA P000006S065
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S065
- Product code
- FHW
- Decision date
- 2023-01-12
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- Manufacturing changes to the adhesive curing process and pump wash procedure
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S065
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2023-01-12
- Decision code
- OK30
- Date received
- 2022-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing changes to the adhesive curing process and pump wash procedure