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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implantable transprostatic tissue retractor system
Regulation Description Implantable transprostatic tissue retractor system.
Definition The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Product CodePEW
Regulation Number 876.5530
Device Class 2


Premarket Reviews
ManufacturerDecision
NEOTRACT, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 4
Use of Device Issue 2
Improper or incorrect procedure or method 2
Patient-device incompatibility 1
Total Device Problems 9

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