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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Product CodeOCL
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 9
CARDIMA, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYOCATH TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
CRYOCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYOGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 8
NCONTACT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 27
Detachment of device component 10
Failure to Adhere or Bond 8
Dislodged or dislocated 6
Material integrity issue 4
Device handling issue 3
Break 3
Other (for use when an appropriate device code cannot be identified) 3
Material separation 2
Loss of or failure to bond 2
Material fragmentation 2
Migration of device or device component 2
No Information 2
Use of Device Issue 2
Component(s), broken 2
Detachment of device or device component 2
Improper or incorrect procedure or method 1
Positioning Issue 1
Temperature issue 1
Failure to power-up 1
Prep, failure to 1
Cautery 1
Inadequate training 1
Component falling 1
Split 1
Device, removal of (non-implant) 1
Visibility/palpability 1
Total Device Problems 91

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 2 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Atricure Inc II Mar-06-2013
2 Cardima Inc II Sep-27-2010
3 St. Jude Medical Atrial Fibrillation Division Inc II Jun-07-2010
4 St. Jude Medical Inc II Jan-30-2009

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