• 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...

6 to 10 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
cadence family of icds P910023/S215 01/29/2010 Review Approval
epic hf crt-d system P030054/S131 01/29/2010 Review Approval
restylane l and perlane l injectable gels P040024/S039 01/29/2010 Review Approval
paradym vr model 8250 & dr model 8550 P980049/S050 04/07/2010 Review Approval
paradym crt-d model 8750 P060027/S015 04/07/2010 Review Approval
-
-