PMA P000006S063
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S063
- Product code
- FHW
- Decision date
- 2022-12-01
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- Manufacturing change to the cylinder bladder dipping and drying process.
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S063
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2022-12-01
- Decision code
- OK30
- Date received
- 2022-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to the cylinder bladder dipping and drying process.