PMA P020003S004
- Device
- COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S004
- Product code
- FAF
- Decision date
- 2006-08-23
- Classification
- Prosthesis, Testicular
- Generic name
- Prosthesis, testicular
- Approval order statement
- APPROVAL TO ADD BLACK INK TO IMPROVE THE VISIBILITY OF THE SERIAL NUMBERS.
Current openFDA PMA Record#
- Device
- COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S004
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2006-08-23
- Decision code
- APPR
- Date received
- 2006-05-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD BLACK INK TO IMPROVE THE VISIBILITY OF THE SERIAL NUMBERS.