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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameCADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantST. JUDE MEDICAL
PMA NumberP910023
Date Received04/23/1991
Decision Date04/30/1993
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 93M-0216
Notice Date 07/22/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
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S128 S129 S130 S131 S132 S133 S134 S135 S136 
S137 S138 S139 S140 S141 S142 S143 S144 S145 
S146 S150 S151 S152 S153 S154 S155 S156 S157 
S158 S159 S160 S161 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 S188 S189 S190 S191 S192 S193 
S194 S195 S196 S197 S198 S199 S200 S201 S202 
S203 S204 S205 S206 S207 S208 S210 S211 S212 
S213 S214 S215 S216 S217 S218 S219 S220 S221 
S222 S223 S224 S225 S226 S227 S228 S229 S230 
S231 S232 S233 S234 S235 S236 S237 S238 S239 
S240 S241 S242 S243 S244 S245 S246 S247 S248 
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S277 S278 S279 S280 S281 S282 S285 S287 S288 
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S321 S322 S323 S324 S325 S327 S328 S329 S330 
S331 S332 S333 S334 S335 S336 S337 S338 S339 
S340 S341 S342 S344 
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