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 |
Premarket Review |
Plastic and Reconstructive Surgery Devices
(DHT4B)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
Submission Type |
PMA
|
Regulation Number |
878.3530
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |