PMA P000006S047
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S047
- Product code
- FHW
- Decision date
- 2017-09-08
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- Approval for addition of 16 cm and 18 cm narrow base zero degree cylinder models.
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S047
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2017-09-08
- Decision code
- APPR
- Date received
- 2017-06-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for addition of 16 cm and 18 cm narrow base zero degree cylinder models.