FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Testicular
PMA: P020003
·
Supplement: S001
·
Decision Feb 5, 2003
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Testicular
- Trade Name
- MENTOR SALINE-FILLED TESTICULAR PROSTHESIS
- PMA Number
- P020003
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- FAF
- Generic Name
- Prosthesis, testicular
- Regulation Number
- 876.3750
- Medical Specialty
- Gastroenterology, Urology
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 5, 2003
- Date Received
- November 7, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR REVISION OF THE POSTAPPROVAL STUDY PROTOCOL TO DISCONTINUE THE REQUIREMENT FOR BLOOD COLLECTION AT THE 5-YEAR EXAM.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FAF | Prosthesis, Testicular | FDA class 3 | Gastroenterology, Urology |