• 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...

56 to 60 of 325 records
 < 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 14 
 15 
 16 
 > 
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
ellipse / fortify assura family of icd's P910023/S342 09/12/2014 Review Approval
quadra assura/unify assura family of crt-d's P030054/S273 09/12/2014 Review Approval
frontier/ frontier ii / anthem family of crt-p's P030035/S123 09/12/2014 Review Approval
microny family of pacemakers P970013/S060 09/12/2014 Review Approval
affinity, integrity, victory, zephyr, & accent family of pacemakers P880086/S245 09/12/2014 Review Approval
-
-