• 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 NameVENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namepulse generator
ApplicantBOSTON SCIENTIFIC
PMA NumberP910077
Date Received12/23/1991
Decision Date06/17/1994
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 94M-0241
Notice Date 08/15/1994
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S004 S006 S007 S008 S009 S010 S011 
S012 S014 S015 S016 S018 S019 S020 S021 S022 
S023 S024 S025 S026 S027 S029 S030 S031 S032 
S033 S035 S036 S037 S038 S039 S040 S041 S042 
S043 S044 S045 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 
S061 S062 S063 S066 S067 S068 S071 S072 S073 
S074 S075 S076 S077 S078 S079 S080 S081 S083 
S084 S086 S087 S088 S089 S090 S091 S092 S093 
S094 S095 S096 S097 S098 S100 S101 S102 S103 
S104 S105 S106 S107 S108 S109 S110 S111 S112 
S113 S115 S116 S117 S118 S119 S120 S121 S122 
S123 S124 S125 S126 S127 S128 S129 S130 S131 
S132 S133 S134 S135 S136 S137 S138 S139 S140 
S141 S142 S143 S144 S145 S146 S147 
-
-