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...

46 to 50 of 325 records
 < 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 14 
 > 
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
mycarelink patient monitor, device data management application, application software P890003/S285 02/14/2014 Review Approval
mycarelink monitor, P890003/S295 02/27/2014 Review Approval
carelink enore programmer,carelink 2090 programmer,carelink home monitor,carelink express monitor,cardiosight reader,dev P890003/S297 07/09/2014 Review Approval
carelink monitor,cardiosight reader,carelink express,device data management application(ddma) P890003/S309 07/03/2014 Review Approval
elite,elite ii,minuet,preva,prodigy,thera d,thera dr ipgs, thera id pg,thera ipg,thera s ipg,thera sr ipg,thera vdd ipg, P890003/S326 10/19/2015 Review Approval
Other Databases
-
-