PMA P020003S001
- Device
- MENTOR SALINE-FILLED TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S001
- Product code
- FAF
- Decision date
- 2003-02-05
- Classification
- Prosthesis, Testicular
- Generic name
- Prosthesis, testicular
- Approval order statement
- APPROVAL FOR REVISION OF THE POSTAPPROVAL STUDY PROTOCOL TO DISCONTINUE THE REQUIREMENT FOR BLOOD COLLECTION AT THE 5-YEAR EXAM.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED TESTICULAR PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P020003
- Supplement
- S001
- Product code
- FAF
- Generic name
- Prosthesis, testicular
- Decision date
- 2003-02-05
- Decision code
- APPR
- Date received
- 2002-11-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR REVISION OF THE POSTAPPROVAL STUDY PROTOCOL TO DISCONTINUE THE REQUIREMENT FOR BLOOD COLLECTION AT THE 5-YEAR EXAM.