• 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...

71 to 75 of 325 records
 < 
 10 
 11 
 12 
 13 
 14 
 15 
 16 
 17 
 18 
 19 
 > 
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
epic hf/atlas+hf hamily of crt-ds P030054/S177 04/04/2011 Review Approval
implantable cv defibrillator/pacemaker programmer/icd monitoring system P000009/S042 04/15/2011 Review Approval
lumax 300/340/500/540 dr/dr-t/vr/vr-t/lumax 540 vr-t dx/kronos lv-t/lumax 300/340/500/540 hf/hf-t P050023/S039 04/15/2011 Review Approval
stratos lv/lv-t P070008/S019 04/15/2011 Review Approval
implantable pacemaker pulse generator,pacemaker programming P950037/S089 04/15/2011 Review Approval
-
-