PMA P000006S017
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S017
- Product code
- FHW
- Decision date
- 2010-07-02
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR A NEW DEVICE PRODUCTION MOLD THAT INCORPORATES A TEAR TRIM AND STRAIN RELIEF FEATURE, AS WELL AS MODIFICATIONS TO ASSOCIATED ENGINEERING DRAWINGS AND DIMENSIONAL TOLERANCE SPECIFICATIONS.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S017
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2010-07-02
- Decision code
- APPR
- Date received
- 2010-01-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW DEVICE PRODUCTION MOLD THAT INCORPORATES A TEAR TRIM AND STRAIN RELIEF FEATURE, AS WELL AS MODIFICATIONS TO ASSOCIATED ENGINEERING DRAWINGS AND DIMENSIONAL TOLERANCE SPECIFICATIONS.