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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ring, annuloplasty
Regulation Description Annuloplasty ring.
Product CodeKRH
Regulation Number 870.3800
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
GENESEE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SORIN
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 909
Adverse Event Without Identified Device or Use Problem 355
Inadequacy of Device Shape and/or Size 77
Device Operates Differently Than Expected 50
Appropriate Term/Code Not Available 46
Gradient Increase 26
Incomplete Coaptation 22
Patient-Device Incompatibility 21
Perivalvular Leak 21
No Apparent Adverse Event 14
Material Separation 13
Calcified 9
Detachment of Device or device Component 7
Off-Label Use 7
Obstruction of Flow 6
Leak / Splash 6
Material Deformation 6
Device Dislodged or Dislocated 5
Material Integrity Problem 5
Improper or Incorrect Procedure or Method 5
Degraded 4
Malposition of device 3
Occlusion Within Device 3
Device Appears to Trigger Rejection 2
Use of Device Problem 2
Material Distortion 2
Fracture 2
Separation Problem 2
Structural Problem 2
Backflow 2
Human-Device Interface Problem 1
Device Damaged Prior to Use 1
Material Fragmentation 1
Material Frayed 1
Biocompatibility 1
Separation Failure 1
Expiration Date Error 1
Material Split, Cut or Torn 1
Bent 1
Device Contamination With Biological Material 1
Split 1
Break 1
Material Twisted / Bent 1
Incorrect, Inadequate or Imprecise Result or Readings 1
Patient Device Interaction Problem 1
Material Rupture 1
Detachment Of Device Component 1
Crack 1
Torn Material 1
Deformation Due to Compressive Stress 1
Total Device Problems 1654


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