PMA P020003S009
- Device
- Torosa Saline Filled Testicular Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S009
- Product code
- FAF
- Decision date
- 2019-10-25
- Classification
- Prosthesis, Testicular
- Generic name
- Prosthesis, testicular
- Approval order statement
- Change to add an additional laser marker to the manufacturing process.
Current openFDA PMA Record#
- Device
- Torosa Saline Filled Testicular Prosthesis
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S009
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2019-10-25
- Decision code
- OK30
- Date received
- 2019-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to add an additional laser marker to the manufacturing process.