PMA P000006S049
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S049
- Product code
- FHW
- Decision date
- 2018-07-27
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- New mixer equipment, new mixing process, and larger capacity filter during mixing process for Bioflex silicone cylinders and reservoirs.
Current openFDA PMA Record#
- Device
- Titan Inflatable Penile Prosthesis (IPP)
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S049
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2018-07-27
- Decision code
- OK30
- Date received
- 2018-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New mixer equipment, new mixing process, and larger capacity filter during mixing process for Bioflex silicone cylinders and reservoirs.