PMA P020003S003
- Device
- SALINE-FILLED TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S003
- Product code
- FAF
- Decision date
- 2004-07-28
- Classification
- Prosthesis, Testicular
- Generic name
- Prosthesis, testicular
- Approval order statement
- APPROVAL TO ADD A CAUTIONARY STATEMENT TO THE OUTER PACKAGING SPECIFYING THAT THE DEVICE SHOULD BE FILLED WITH SALINE PRIOR TO IMPLANTATION.
Current openFDA PMA Record#
- Device
- SALINE-FILLED TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S003
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2004-07-28
- Decision code
- APPR
- Date received
- 2004-07-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD A CAUTIONARY STATEMENT TO THE OUTER PACKAGING SPECIFYING THAT THE DEVICE SHOULD BE FILLED WITH SALINE PRIOR TO IMPLANTATION.