Device |
agents, embolic, for treatment of benign prostatic hyperplasia |
Regulation Description |
Prostatic artery embolization device. |
Definition |
The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH). |
Physical State |
Beads in suspension |
Technical Method |
A catheter is threaded from femoral artery to the prostatic artery and beads are injected until stasis in flow is achieved. |
Target Area |
Prostate |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | NOY |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
876.5550
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |