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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agents, embolic, for treatment of benign prostatic hyperplasia
Definition The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).
Product CodeNOY
Regulation Number 876.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOCOMPATIBLES UK LTD (PART OF BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Pain 3 3
Thrombosis 2 2
Lethargy 2 2
Test Result 1 1
Low Oxygen Saturation 1 1
Cognitive Changes 1 1
Death 1 1
Dysphagia/ Odynophagia 1 1
Renal Failure 1 1
Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MICROVENTION INC. II Jan-31-2024
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