PMA P000006S003
- Device
- MENTOR TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S003
- Product code
- FHW
- Decision date
- 2003-07-14
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR MARKETING CLAIMS REGARDING WATER ABSORPTION BY THE TITAN INFLATABLE PENILE PROSTHESIS.
Current openFDA PMA Record#
- Device
- MENTOR TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S003
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2003-07-14
- Decision code
- APPR
- Date received
- 2002-10-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MARKETING CLAIMS REGARDING WATER ABSORPTION BY THE TITAN INFLATABLE PENILE PROSTHESIS.