PMA P000006S044
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S044
- Product code
- FHW
- Decision date
- 2015-02-23
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL TO IMPLEMENT AN ADDITIONAL IN-PROCESS TEST DURING THE MANUFACTURING OF THE TITAN TOUCH PUMP.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S044
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2015-02-23
- Decision code
- APPR
- Date received
- 2015-02-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO IMPLEMENT AN ADDITIONAL IN-PROCESS TEST DURING THE MANUFACTURING OF THE TITAN TOUCH PUMP.