PMA P020003S002
- Device
- MENTOR SALINE-FILLED TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S002
- Product code
- FAF
- Decision date
- 2004-03-18
- Classification
- Prosthesis, Testicular
- Generic name
- Prosthesis, testicular
- Approval order statement
- CHANGE INVOLVING THE ENGRAVING PROCESS, A CHANGE IN A RAW MATERIAL SUPPLIER AND A MINOR CHANGE IN THE MOLDING PROCESS.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S002
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2004-03-18
- Decision code
- OK30
- Date received
- 2004-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE INVOLVING THE ENGRAVING PROCESS, A CHANGE IN A RAW MATERIAL SUPPLIER AND A MINOR CHANGE IN THE MOLDING PROCESS.