Device |
occluder, balloon, vena-cava |
Review Panel |
Cardiovascular |
Product Code | LWT |
Premarket Review |
Coronary and Peripheral Interventional Devices
(DHT2C)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|