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...

26 to 30 of 325 records
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
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
affinity, integrity, victory, zephyr, & accent family of pacemakers P880086/S245 09/12/2014 Review Approval
affinity/integrity / victory /zephyr accent family of pacemakers P880086/S255 08/27/2015 Review  
carelink monitor & cardiosight reader P890003/S169 04/04/2011 Review Approval
medtronic carelink monitor model 2490c, cardiosight reader P890003/S177 03/25/2011 Review Approval
carelink home monitor model 2490c, cardiosight reader model 2020a, caelink network device P890003/S179 01/09/2012 Review Approval
Other Databases
-
-