PMA P000006S018
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S018
- Product code
- FHW
- Decision date
- 2010-01-15
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- MODIFICATION OF THE RESERVOIR DIP COATING PROCESS USING A NEW PIECE OF EQUIPMENT.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S018
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2010-01-15
- Decision code
- OK30
- Date received
- 2009-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF THE RESERVOIR DIP COATING PROCESS USING A NEW PIECE OF EQUIPMENT.