Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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...

226 to 230 of 325 records
 < 
 41 
 42 
 43 
 44 
 45 
 46 
 47 
 48 
 49 
 50 
 > 
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 family of icds P910023/S264 08/03/2011 Review Approval
frontier/frontierii/anthem family of crt-ps P030035/S083 08/03/2011 Review Approval
microny family of pacemakers P970013/S040 08/03/2011 Review Approval
epic hf/atlas + hf family of crt-ds P030054/S189 08/03/2011 Review Approval
affinity/integrity/victory/zephyr/accent family of pacemakers P880086/S203 08/03/2011 Review Approval
Other Databases
-
-