PMA P020003
- Device
- Coloplast Saline-Filled Testicular Prosthesis (Torosa)
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S011
- Product code
- FAF
- Decision date
- 2022-09-16
- Generic name
- Prosthesis, testicular
- Approval order statement
- Implementation of a size inspection step for the Torosa Saline Filled Testicular Prosthesis (SFTP) during manufacturing.
Current openFDA PMA Record#
- Device
- Coloplast Saline-Filled Testicular Prosthesis (Torosa)
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S011
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2022-09-16
- Decision code
- OK30
- Date received
- 2022-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a size inspection step for the Torosa Saline Filled Testicular Prosthesis (SFTP) during manufacturing.