• 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...

201 to 229 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
cadence/ellipse/fortify assura family of icds P910023/S279 05/07/2012 Review Approval
cadence/ellipse/fortify assura family of icd's P910023/S297 04/10/2014 Review Approval
cadence/current/fortify families of icds P910023/S257 06/21/2011 Review Approval
cadence family of icds P910023/S236 03/04/2011 Review Approval
cadence family of icds P910023/S270 03/09/2012 Review Approval
cadence family of icds P910023/S215 01/29/2010 Review Approval
cadence family of icds P910023/S254 04/04/2011 Review Approval
cadence family of icds P910023/S264 08/03/2011 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
belos/lexos dr/dr-t/vr/vr-t, lumos dr-t, & xelos dr-t icds P000009/S040 11/26/2010 Review Approval
belos dr/dr-t/vr/vr-t/lexos dr/dr-t/vr/vr-t/lumos dr-t/vr-t/xelos dr-t P000009/S047 05/04/2012 Review Approval
belos dr/dr-t/vr/vr-t, lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's P000009/S049 10/03/2012 Review Approval
belos & lexos dr/dr-t/vr/vr-t, lumos dr-t/vr-t, xelos dr-t icd's P000009/S051 03/18/2013 Review Approval
atlas ii/+, epic +/ii/ii+, current rf/+/accel, fortify icds P910023/S263 12/04/2012 Review Approval
atlas +hf, epic hf/+hf, promote rf/+/accel, unify crt-ds P030054/S188 12/04/2012 Review Approval
anthem, frontier ii crt-ps P030035/S082 12/04/2012 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S211 05/07/2012 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S220 04/10/2014 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S229 06/06/2013 Review Approval
affinity/integrity/victory family of pacemakers P880086/S189 03/04/2011 Review Approval
affinity/integrity/victory family of pacemakers P880086/S195 04/04/2011 Review Approval
advisa dr ipg P980035/S134 04/04/2011 Review Approval
advisa dr ipg P980035/S264 06/04/2012 Review Approval
adapta,versa,sensia,advisa dr,advisa dr mri,enpulse e1,enpulse e2,enrhythm,kappa d(kappa 700),kappa d (kappa 900) ipg, k P980035/S338 09/27/2013 Review Approval
adapta, versa, sensia ipg, advisa dr ipg, dr mri ipg, enpulse el ipg, e2 ipg, enrhythm ipg, kappa d ipg P980035/S343 02/14/2014 Review Approval
adapta versa, sensia ipg, advisa dr ipg, advisa dr mri ipg and enpulse e1 ipg P980035/S311 05/24/2013 Review Approval
ace header/lead end pin cap/epicardial patch lead/accessory (upsizing sleeve) for unipolar P900061/S098 05/13/2011 Review Approval
accent, identity, identity adx, integrity adx, verity adx, victory, zepher, microny pacemakers P880086/S202 12/04/2012 Review Approval
 
 < 
 1 
 2 
 3 
 4 
 5 
 
 
-
-