FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Testicular
PMA: P020003
·
Supplement: S005
·
Decision Oct 9, 2007
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Prosthesis, Testicular
- Trade Name
- COLOPLAST SALINE-FILLED TESTICULAR IMPLANT
- PMA Number
- P020003
- Supplement Number
- S005
- 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
- October 9, 2007
- Date Received
- July 23, 2007
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR LABELING CHANGES TO REPORT POST APPROVAL STUDY RESULTS.
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 |