PMA P020003S005
- Device
- COLOPLAST SALINE-FILLED TESTICULAR IMPLANT
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S005
- Product code
- FAF
- Decision date
- 2007-10-09
- Classification
- Prosthesis, Testicular
- Generic name
- Prosthesis, testicular
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO REPORT POST APPROVAL STUDY RESULTS.
Current openFDA PMA Record#
- Device
- COLOPLAST SALINE-FILLED TESTICULAR IMPLANT
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S005
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2007-10-09
- Decision code
- APPR
- Date received
- 2007-07-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO REPORT POST APPROVAL STUDY RESULTS.