• 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 223 of 223 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
stratos lv/lv-t P070008/S031 10/03/2012 Review Approval
stratos lv/lv-t crt-p P070008/S017 11/26/2010 Review Approval
stratos lv/lv-t, evia and entovis hf/hf-t crt-p's P070008/S036 03/18/2013 Review Approval
subcutaneous implantable defibrillator (s-icd) system P110042/S009 08/28/2013 Review Approval
surgifoam hemostatic matrix and surgiflo hemostatic matrix kit with thrombin P990004/S019 05/17/2011 Review Approval
synergyst ii pacing system P890003/S265 05/30/2013 Review Approval
teligen 4-site models P960040/S198 11/10/2010 Review Approval
teligen, incepta, energen and punctua icd devices P960040/S270 11/30/2012 Review Approval
tendril family of leads P960013/S068 09/13/2012 Review Approval
tendril sts 1988tc and 2088tc P960013/S066 11/01/2011 Review Approval
tendril sts lead model 1988tc P960013/S054 04/14/2010 Review Approval
transcyte human fibroblast-derived temporary skin substitute P960007/S021 09/20/2011 Review Approval
transvene cs/svc lead P980050/S057 05/13/2011 Review Approval
unify crt-d system P030054/S141 05/07/2010 Review Approval
unify quadra crt-d, unify quadra assura P030054/S223 08/09/2012 Review Approval
various families of philos, cylos, evia, entovis, estella, ecuro, & effecta implantable pacemakers P950037/S105 10/03/2012 Review Approval
various models of ipg's: actros, axios, cylos, dromos, kairos, philos/ii, protos, etc. P950037/S116 03/18/2013 Review Approval
various models of lumax icd/crt-d families P050023/S033 11/26/2010 Review Approval
versatrax pacing system P820003/S117 05/30/2013 Review Approval
vigila and volta and passive fixation bipolar steroid eluting icd leads P980023/S046 02/22/2012 Review Approval
virtuoso ii/secura/maximo ii icds P980016/S273 05/13/2011 Review Approval
vistatron c&t series (model vsf04 v8.0, model vsf 12 v8.0, model vsf08 v8.0) P990001/S105 03/13/2013 Review Approval
xc202 ceramic capacitor P980035/S153 06/18/2010 Review Approval
 
 < 
 1 
 2 
 3 
 4 
 5 
 
 
-
-