FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Testicular
PMA: P020003
·
Decision Jul 19, 2002
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Testicular
- Trade Name
- COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
- PMA Number
- P020003
- 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
- July 19, 2002
- Date Received
- January 22, 2002
- Expedited Review
- Y
- Docket Number
- 02M-0322
Advisory Committee Statement
APPROVAL FOR THE MENTOR SALINE-FILLED TESTICULAR PROSTHESIS. THE DEVICE IS INDICATED FOR USE WHEN COSMETIC TESTICULAR REPLACEMENT IS INDICATED; I.E., IN THE CASE OF AGENESIS OR FOLLOWING THE SURGICAL REMOVAL OF A TESTICLE.
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 |