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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia
Definition A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Product CodeQKA
Regulation Number 876.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDI-TATE LTD.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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