FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Prosthesis, Testicular
PMA: P020003
·
Supplement: S008
·
Decision Sep 4, 2018
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Testicular
- Trade Name
- Torosa Saline Filled Testicular Prosthesis
- PMA Number
- P020003
- Supplement Number
- S008
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 4, 2018
- Date Received
- August 6, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Use of a new peel-test equipment.
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 |