Device |
agent, occluding, vascular, permanent |
Definition |
The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels. |
Physical State |
The device consists of a polymerizing glue and delivery system for injection into the vasculature. |
Technical Method |
The material polymerizes in the vessel to permanently coapt or occlude the vessel. |
Target Area |
Peripheral vasculature |
Review Panel |
Cardiovascular |
Product Code | PJQ |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
PMA
|
Device Class |
3
|
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 |