PMA P000006S031
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S031
- Product code
- FHW
- Decision date
- 2013-02-14
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- REPLACEMENT OF EXISTING TESTING EQUIPMENT USED IN THE MANUFACTURING PROCESS OF THE DEVICE.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S031
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2013-02-14
- Decision code
- OK30
- Date received
- 2013-01-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACEMENT OF EXISTING TESTING EQUIPMENT USED IN THE MANUFACTURING PROCESS OF THE DEVICE.