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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dissolvable gel for preventing ureteral stone migration
Definition For use in the ureter to prevent the migration of urinary calculi and their fragments during intracorporeal lithotripsy procedures.
Product CodeONJ
Regulation Number 876.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
PLUROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Complaint, Ill-Defined 1 1

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