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...

1 to 5 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
natrelle silicone filled breast implants P020056/S054 10/27/2021   Approval
natrelle saline filled breast implants P990074/S045 10/27/2021   Approval
memorygel/memorygel xtra breast implants P030053/S062 10/27/2021   Approval
memoryshape breast implants P060028/S041 10/27/2021   Approval
saline-filled and spectrum breast implants P990075/S051 10/27/2021   Approval
Other Databases
-
-