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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device negative pressure wound therapy device for reduction of wound complications
Definition A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.
Product CodeQFC
Regulation Number 878.4783
Device Class 2


Premarket Reviews
ManufacturerDecision
3M
  SUBSTANTIALLY EQUIVALENT 1
KCI USA, INC.
  GRANTED 1
SMITH AND NEPHEW MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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