PMA P000006S057
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S057
- Product code
- FHW
- Decision date
- 2020-10-01
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- Adding an additional Rotate and Dip (RAD) machine.
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S057
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2020-10-01
- Decision code
- OK30
- Date received
- 2020-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an additional Rotate and Dip (RAD) machine.