PMA P000006S036
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S036
- Product code
- FHW
- Decision date
- 2014-08-25
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR TO USE A NEW VENDOR/ ADDITIONAL SUPPLIER AND A NEW MOLD.
Current openFDA PMA Record#
- Device
- TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S036
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2014-08-25
- Decision code
- APPR
- Date received
- 2014-02-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR TO USE A NEW VENDOR/ ADDITIONAL SUPPLIER AND A NEW MOLD.