Device |
shockwave intravascular lithotripsy system |
Definition |
Dilatation of coronary arteries prior to stenting |
Physical State |
Catheter, connector cables, generator. |
Technical Method |
Percutaneous, intravascular delivery of the device to lesions in the coronary arteries |
Target Area |
Coronary arteries |
Review Panel |
Cardiovascular |
Product Code | QMG |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
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 |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |