PMA P020003S007
- Device
- TOROSA TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S007
- Product code
- FAF
- Decision date
- 2010-11-10
- Classification
- Prosthesis, Testicular
- Generic name
- Prosthesis, testicular
- Approval order statement
- APPROVAL FOR THE CHANGE OF THE SALINE FILLED TESTICULAR PROSTHESIS AND THE RE-BRANDING TO ¿TOROSA TESTICULAR PROSTHESIS¿.
Current openFDA PMA Record#
- Device
- TOROSA TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S007
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2010-11-10
- Decision code
- APPR
- Date received
- 2010-08-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE CHANGE OF THE SALINE FILLED TESTICULAR PROSTHESIS AND THE RE-BRANDING TO ¿TOROSA TESTICULAR PROSTHESIS¿.