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Implantable Transprostatic Tissue Retractor System

FDA product code PEW · 10 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5530
Review panel
GU
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2013-12-20 – 2023-09-22

The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

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