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...

91 to 95 of 325 records
 < 
 14 
 15 
 16 
 17 
 18 
 19 
 20 
 21 
 22 
 23 
 > 
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 monitor, P890003/S295 02/27/2014 Review Approval
brava crt-d,viva s crt-d,viva xt crt-d,viva/brava/evera programmer application software P010031/S413 02/27/2014 Review Approval
ellipse/fortify assura family of icds P910023/S323 02/26/2014 Review Approval
frontier/frontier ii/ anthem family of crt-ps P030035/S115 02/26/2014 Review Approval
quadra assura/unify assura family pf crt-ds P030054/S254 02/26/2014 Review Approval
Other Databases
-
-