FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Testicular
PMA: P020003
·
Supplement: S004
·
Decision Aug 23, 2006
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Testicular
- Trade Name
- COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
- PMA Number
- P020003
- Supplement Number
- S004
- 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
- August 23, 2006
- Date Received
- May 18, 2006
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO ADD BLACK INK TO IMPROVE THE VISIBILITY OF THE SERIAL NUMBERS.
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 |