PMA P000006S038
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S038
- Product code
- FHW
- Decision date
- 2014-11-04
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO STRENGTHEN EXISTING INSTRUCTIONS ON PUMP FILLING AND ACTIVATION.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S038
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2014-11-04
- Decision code
- APPR
- Date received
- 2014-10-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO STRENGTHEN EXISTING INSTRUCTIONS ON PUMP FILLING AND ACTIVATION.