• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

  • Print
  • Share
  • E-mail
-

As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Links to all available summary review memos can be found here.

Learn more...

151 to 200 of 229 records
 < 
 1 
 2 
 3 
 4 
 5 
 > 
results per page
Device
Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
PMA
Number
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
Review
Memo
Approval
Order
protecta xt crt-d and protecta crt-d implantable cardioverter defibrillators with cardiac resynchronization; model sw009 P010031/S171 03/25/2011 Review Approval
medtronic consulta crt-d d204trm, maximo ii crt-d d264trm implantable cardioverter defibrillators P010031/S176 01/09/2012 Review Approval
medtronic protecta xt crt-d d314trm and protecta crt-d d334 implantable cardioverter defibrillators P010031/S178 11/09/2011 Review Approval
consulta crt-p, syncra crt-p P010015/S190 05/24/2013 Review Approval
concerto ii/consulta/maximo ii crt-ds P010031/S198 03/22/2011 Review Approval
consulta crt-p,syncra crt-p P010015/S208 09/27/2013 Review Approval
cognis 4-site models P010012/S212 11/10/2010 Review Approval
consulta crt-p, syncra crt-p P010015/S215 02/14/2014 Review Approval
concerto ii/maximo ii/consulta crt-ds P010031/S228 05/13/2011 Review Approval
concerto ii/consulta/insync ii marquis/iii marquis/insync maximo/sentry/maximo ii/protecta/protecta xt P010031/S252 08/18/2011 Review Approval
incepta, energen, punctua and cognis crt-d P010012/S255 11/17/2011 Review Approval
concert ii, consulta, & maximo ii crt-ds P010031/S296 06/04/2012 Review Approval
cognis, incepta, energen and punctua crt-d devices P010012/S300 11/30/2012 Review Approval
consulta crt-p, advisa (model 9995 v8.0) consulta crt-d, secura (model 9995 v8.0) insync iii, maximo ii, concerto ii P010031/S319 03/13/2013 Review Approval
concerta, consulta/consulta df4, & various insync families of icd's; concerto ii, maximo ii,protecta,protecta xt crt-d's P010031/S329 10/26/2012 Review Approval
dynagen & dynagen x4 crt-d's; inogen & inogen x4 crt-d's; origen & origen x4 crt-d's; cognis crt-d P010012/S341 04/11/2014 Review Approval
insync ii p rotect icd, insync iii marquis icd, insync marquis icd, insync maximo icd P010031/S363 05/24/2013 Review Approval
insync ii protect, insync iii marquis,insync marquis, insync maximo icds P010031/S386 09/27/2013 Review Approval
insync ii protect icd, iiimarquis icd, marquis icd, maximo icd, brava crt-d, concerto icd, ii crt-d, consulta icd, maxim P010031/S397 02/14/2014 Review Approval
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software P010031/S413 02/27/2014 Review Approval
medtronic selectsecure lead model 3830 P030036/S004 03/30/2011 Review Approval
frontier/frontier 2 family of crt-ps P030035/S070 03/04/2011 Review Approval
frontier/frontier ii family of crt-ps P030035/S075 04/04/2011 Review Approval
invive v172, v173 P030005/S079 05/01/2012 Review Approval
anthem, frontier ii crt-ps P030035/S082 12/04/2012 Review Approval
frontier/frontierii/anthem family of crt-ps P030035/S083 08/03/2011 Review Approval
cardiac resynchronization therapy-pacemaker (crt-p) models v172 and v173 P030005/S088 03/12/2013 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S089 05/07/2012 Review Approval
intua cardiac resynchronization therapy-pacemaker (crt-p) P030005/S092 05/23/2013 Review Approval
frontier/ frontier ii /anthem family of crt-p's P030035/S098 04/10/2014 Review Approval
frontier/frontier ii/anthem family of crt-ps P030035/S107 06/06/2013 Review Approval
quickflex u model 1258t lead P030054/S130 05/10/2010 Review Approval
epic hf crt-d system P030054/S131 01/29/2010 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
st jude medical, merlin psa ex3100 system P030054/S146 05/03/2010 Review Approval
epic hr/atlas + hf family of crt-ds P030054/S153 03/04/2011 Review Approval
cardiac resynchronization therapy defibrillator (crt-d) P030054/S173 11/29/2011 Review Approval
epic hf/atlas+hf hamily of crt-ds P030054/S177 04/04/2011 Review Approval
epic hf/atlas+hf/promote/unify families of crt-ds P030054/S181 06/21/2011 Review Approval
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
epic hf/atlas + hf family of crt-ds P030054/S189 08/03/2011 Review Approval
epic hf/atlas + hf family P030054/S196 03/09/2012 Review Approval
epic hf/atlas+hf/quadra assura/unify assura family of crt-ds P030054/S206 05/07/2012 Review Approval
unify quadra crt-d, unify quadra assura P030054/S223 08/09/2012 Review Approval
epic hf/atlas + hf/quandra assura/unify assura family of crt-d's P030054/S226 04/10/2014 Review Approval
merlin net 6.1m P030054/S237 12/19/2012 Review Approval
quadra assura/unify assura family of crt-ds P030054/S238 06/06/2013 Review Approval
restylane l and perlane l injectable gels P040024/S039 01/29/2010 Review Approval
restylane injectable gel P040024/S052 07/18/2011 Review Approval
juvederm ultra xc and juvederm ultra plus xc P050047/S005 01/07/2010 Review Approval
 
 < 
 1 
 2 
 3 
 4 
 5 
 > 
 
-
-