- Device
- Coloplast Saline-Filled Testicular Prosthesis (Torosa)
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S010
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2022-08-24
- Decision code
- OK30
- Date received
- 2022-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of the Kinetic Turbidimetric method to perform Bacterial Endotoxin testing for the Coloplast Saline-Filled Testicular Prosthesis (Torosa).