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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device colon capsule imaging system
Regulation Description Colon capsule endoscopy system.
Definition visualization of the colon for the detection of polyps
Product CodePGD
Regulation Number 876.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
GIVEN IMAGING
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 1
Total Device Problems 1

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