Device |
ablation catheter, renal denervation |
Definition |
For denervating the renal nerves to lower blood pressure |
Physical State |
Catheter and generator |
Technical Method |
Catheter delivered near the renal nerves to deliver energy to cause denervation |
Target Area |
Renal vasculature and nerves |
Review Panel |
Cardiovascular |
Product Code | QYI |
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 |