Device |
drug coated prostatic dilation catheter for benign prostatic hyperplasia |
Definition |
dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia |
Physical State |
drug-coated balloon catheter |
Technical Method |
exert radial force to dilate narrow prostatic urethra |
Target Area |
prostatic urethra |
Review Panel |
Gastroenterology/Urology |
Product Code | QXB |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
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 |
|
|