FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Prosthesis, Testicular
PMA: P020003
·
Supplement: S009
·
Decision Oct 25, 2019
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
- S009
- 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
- October 25, 2019
- Date Received
- September 27, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change to add an additional laser marker to the manufacturing process.
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 |