Product code PEW
- Device name
- Implantable Transprostatic Tissue Retractor System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5530
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
- Source
- FDA openFDA device classification dataset