• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 240
No Information 86
Deterioration of prosthesis 80
Perivalvular leak 52
Size incorrect for patient 48
Other (for use when an appropriate device code cannot be identified) 48
No code available 29
Explanted 13
Incomplete coaptation 10
Calcified 8
Fracture 7
Leak 7
Performance 5
Patient-device incompatibility 5
Device operates differently than expected 5
Gradient increase 4
Degraded 3
Difficult to deploy 3
Human-Device Interface Issue 3
Material integrity issue 3
Material separation 2
Tears, rips, holes in device, device material 2
Structural problem 2
Detachment of device component 2
Device remains implanted 2
Replace 2
Material rupture 1
User used incorrect product for intended use 1
Break 1
Material fragmentation 1
Material frayed 1
Blood pooling 1
Cut in material 1
Improper or incorrect procedure or method 1
Material deformation 1
Detachment of device or device component 1
Failure to separate 1
Fibrosis 1
Malposition of device 1
Total Device Problems 3739

-
-