| Device |
prosthesis, breast, inflatable, internal, saline |
| Regulation Description |
Silicone inflatable breast prosthesis. |
| Definition |
Call for pmas to be filed by 11/17/99 per 64 fr 45161 on 8/19/99. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | FWM |
|---|
| Submission Type |
PMA
|
|---|
| Regulation Number |
878.3530
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Saline, Silicone Gel, and Alternative Breast Implants - Draft Guidance for Industry and FDA Staff
|
|
| Third Party Review |
Not Third Party Eligible |
|
|
