• 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
consulta & syncra crt-ps implantable pulse generator with cardiac resynchronization P010015/S084 03/22/2011 Review Approval
carelink monitor models 2490g/2491ddma P890003/S189 03/22/2011 Review Approval
dema ipg/c & t series ipgs P990001/S068 03/22/2011 Review Approval
carelink ddma software and carelink monitor P890003/S192 03/22/2011 Review Approval
kappa 400 dr/sr ipg P970012/S068 03/22/2011 Review Approval
-
-