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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
BAXTER HEALTHCARE CORP.
  SE - POSTMARKET SURVEILLANCE REQUIRED 2
  SUBSTANTIALLY EQUIVALENT 3
CARBOMEDICS, INC.
  1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 6
GENESEE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDICALCV, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  1
  SUBSTANTIALLY EQUIVALENT 10
MICARDIA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SHELHIGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
SORIN
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  1
  SUBSTANTIALLY EQUIVALENT 9
SULZER
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Unknown (for use when the device problem is not known) 2615
Paravalvular leak 440
No Known Device Problem 221
Deterioration of prosthesis 80
No Information 55
Perivalvular leak 52
Other (for use when an appropriate device code cannot be identified) 48
Size incorrect for patient 46
No code available 27
Explanted 13
Calcified 7
Fracture 7
Leak 7
Incomplete coaptation 5
Patient-device incompatibility 5
Device operates differently than expected 5
Performance 5
Human-Device Interface Issue 3
Degraded 3
Difficult to deploy 3
Replace 2
Gradient increase 2
Structural problem 2
Tears, rips, holes in device, device material 2
Detachment of device component 2
Device remains implanted 2
Failure to separate 1
Material fragmentation 1
User used incorrect product for intended use 1
Material deformation 1
Malposition of device 1
Material rupture 1
Blood pooling 1
Cut in material 1
Detachment of device or device component 1
Break 1
Improper or incorrect procedure or method 1
Fibrosis 1
Material frayed 1
Total Device Problems 3672

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