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).
| Device Type ID | 2040 |
| Device Name | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia |
| 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 Description | Prostatic Artery Embolization Device. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NOY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2040 |
| Device | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia |
| Product Code | NOY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Prostatic Artery Embolization Device. |
| CFR Regulation Number | 876.5550 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOSPHERE MEDICAL, INC. | ||
GRANTED | 1 | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |