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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device absorbable lung biopsy plug
Definition A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.
Product CodeOMT
Regulation Number 878.4755
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIOTECH
  GRANTED 1

MDR Year MDR Reports MDR Events
2018 1 1
2020 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 2 2
Activation Problem 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pneumothorax 1 1
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Surgical Specialties Mexico S DE RL DE CV II Oct-11-2016
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