• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NameMEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cdardioverter defibrillator system
Applicant MEDTRONIC INC.
PMA NumberP980050
Date Received12/24/1998
Decision Date06/14/2000
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 00M-1389
Notice Date 07/12/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the medtronic(r) jewel(r) af 7250 dual chamber implantable cardioverter defibrillator (icd), model 9961 programmer application software, and medtronic(r) sprint(tm) model 6943 steroid eluting, screw-in, atrial/ventricular lead. This system is indicated for use in icd patients either with atrial tachyarrhythmias or who are at significant risk of developing atrial tachyarrhythmias. Patients indicated for an icd are those patients who are at risk of sudden death due to ventricular.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S013 S014 S015 S016 S019 S020 S021 
S022 S023 S024 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S055 S056 S057 S058 
S059 S060 S061 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 S079 S080 S081 S082 S083 S084 S085 
S086 S087 S088 S089 S090 S091 S093 S094 S095 
-
-