PMA P000006S046
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S046
- Product code
- FHW
- Decision date
- 2017-05-17
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- Approval for addition of a new insertion tool; update of pusher tool design; addition of shods supplied with kit; modification of package layout and material; use of new package denesting agent; and 2 year and 5 year shelf-life protocol.
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S046
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2017-05-17
- Decision code
- APPR
- Date received
- 2017-02-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for addition of a new insertion tool; update of pusher tool design; addition of shods supplied with kit; modification of package layout and material; use of new package denesting agent; and 2 year and 5 year shelf-life protocol.