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

Premarket Approval (PMA)

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


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
ApplicantGUIDANT CORP.
PMA NumberP030005
Date Received03/24/2003
Decision Date01/26/2004
Product Code
NKE[ Registered Establishments with NKE ]
Docket Number 04M-0064
Notice Date 02/24/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the contak renewal tr. The device is indicated s follows: the contak renewal tr pulse generator is indicated for patients who have moderate to severe heart failure (nyha class iii/iv) including left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms and remain symptomatic despite stable, optimal heart failure drug therapy (as defined in the clinical trials section). The device provides atrial-ventricular tracking modes to help preserve av synchrony, and adaptive-rate pacing for patients who would benefit from adjusted pacing rates concurrent with physical activity.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S018 S019 S020 
S021 S022 S023 S024 S027 S028 S029 S030 S031 
S032 S033 S034 S035 S037 S039 S040 S041 S042 
S043 S044 S046 S047 S048 S049 S050 S051 S052 
S053 S054 S055 S056 S057 S058 S059 S060 S061 
S062 S063 S064 S065 S067 S068 S069 S070 S071 
S072 S073 S074 S075 S076 S077 S078 S079 S080 
S081 S082 S083 S084 S085 S086 S087 S088 S089 
S090 S092 S093 S094 S096 S097 S098 S099 S100 
S101 S102 S103 S104 S105 
-
-