PMA P250007
- Device
- Zenflow Spring® Implant and Delivery System
- Applicant
- Zenflow, Inc.
- PMA number
- P250007
- Product code
- MER
- Decision date
- 2025-12-11
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- The Zenflow Spring Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25 and 45 mm and prostate sizes between 25 and 80 cc.
Current openFDA PMA Record
- Device
- Zenflow Spring® Implant and Delivery System
- Applicant
- Zenflow, Inc.
- PMA number
- P250007
- Product code
- MER
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2025-12-11
- Decision code
- APPR
- Date received
- 2025-03-11
- Approval order statement
- The Zenflow Spring Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25 and 45 mm and prostate sizes between 25 and 80 cc.