PMA P000006S014
- Device
- TITAN INFLATABLE PENILE PROSTHESIS (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S014
- Product code
- FHW
- Decision date
- 2009-05-29
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR A CHANGE IN EQUIPMENT USED DURING THE MANUFACTURING DIPPING PROCESS FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S014
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2009-05-29
- Decision code
- APPR
- Date received
- 2008-12-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN EQUIPMENT USED DURING THE MANUFACTURING DIPPING PROCESS FOR THE DEVICE.