PMA P000006S009
- Device
- COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S009
- Product code
- FHW
- Decision date
- 2008-05-23
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR A CHANGE OF ACCELERATED AGING TEMPERATURE FROM 65 DEGREES C TO 60 DEGREES C IN A STABILITY PROTOCOL FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S009
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2008-05-23
- Decision code
- APPR
- Date received
- 2008-03-11
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR A CHANGE OF ACCELERATED AGING TEMPERATURE FROM 65 DEGREES C TO 60 DEGREES C IN A STABILITY PROTOCOL FOR THE DEVICE.