PMA P000006S033
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S033
- Product code
- FHW
- Decision date
- 2013-05-31
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DEFLATION BUTTON AND VALVE OF THE PUMP COMPONENT, AND RELATED CHANGES TO THE LABELING TO REFLECT THESE MODIFICATIONS.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S033
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2013-05-31
- Decision code
- APPR
- Date received
- 2013-04-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DEFLATION BUTTON AND VALVE OF THE PUMP COMPONENT, AND RELATED CHANGES TO THE LABELING TO REFLECT THESE MODIFICATIONS.