| Device |
carbon dioxide gas controlled tissue expander |
| Regulation Description |
Carbon dioxide gas controlled tissue expander. |
| Definition |
A carbon dioxide gas controlled tissue expander is intended for tissue expansion. |
| Physical State |
It includes an inflatable elastomer shell with an implanted canister containing compressed carbon dioxide. It includes a remote controller that communicates with the implanted tissue expander to release carbon dioxide from the implanted canister into the shell. |
| Technical Method |
A carbon dioxide gas controlled tissue expander is made of an inflatable elastomer shell and is filled with carbon dioxide gas. It utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the tissue expander. |
| Target Area |
Breasts, soft tissue |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | PQN |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.3510
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
