Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 | HDE | Classification | Standards
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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP980049
Date Received12/18/1998
Decision Date09/15/1999
Product Code MRM 
Docket Number 00M-0915
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have expierienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 2) recurrent poorly tolerated, sustained ventricular tachycardia (VT).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S038 S039 S053 S054 S055 S126 S005 S001 S012 S013 S014 S015 
S016 S010 S011 S026 S027 S049 S061 S004 S056 S057 S058 S059 
S009 S008 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 
S072 S073 S074 S075 S076 S077 S090 S091 S092 S093 S094 S095 
S096 S097 S098 S099 S100 S101 S102 S103 S104 S105 S106 S107 
S108 S109 S110 S111 S112 S113 S114  S124 S078 S079 S080 
S081 S082 S083 S085 S086 S087 S088 S051 S089 S125 S115 S116 
S117 S118 S119 S022 S023 S017 S018 S003 S019 S020 S021 S046 
S047 S048 S123 S120 S121 S122 S002 S028 S024 S060 S029 S030 
S031 S032 S033 S034 S035 S036 S006 S007 S050 S040 S041 S042 
S025 S037 S043 S044 S045 S129 S134 S136 S142 S145 S131 S127 
S128 S130 S132 S133 S138 S139 S141 S137 S140 S135 S144 S143 
-
-