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.
 
DeviceEDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Date Received11/18/1986
Decision Date09/26/1991
Product Code DYE 
Docket Number 91M-0397
Notice Date 11/12/1991
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the Carpentier-Edwards® Pericardial Bioprosthesis, Model 2700. This device is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement.
Supplements:  S001 S003 S004 S006 S009 S010 S011 S012 S013 S014 S015 
S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S044 S045 S046 S047 S048 S050 S051 S052 S053 
S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 
S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 S078 
S079 S081 S082 S083 S085 S086 S087 S088 S089 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 S115 S116 
S117 S118 S119 S120 S121 S122 S123 S124 S125 S126 S127 S128 
S129 S130 S131 S132 S134 S135 S136 S137 S138 S139 S141 S142 
S143 S144 S145 S146 S147 S149 S150 S151 S152 S153 S154 S156 
S157 S158 S159 S160 S162 S163 S164 S165 S166 S167 S168 S169 
S170 S171 S172 S173 S174 S175 S176 S177 S178 S179 S180 S181 
S182 S183 S184 S185 S186 S187 S189 S190 S191 S192 S193 S194 
S195 S196 S197 S198 S199 S200 S201 S202 S203 S204 S205 S206 
S207 S208 S209 S210 S212 S213 S214 S215 S216 S217 S218 S219 
-
-