• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Classification Nameinsert, tubal occlusion
Generic Namedevice, occlusion, tubal, contraceptive
Regulation Number884.5380
ApplicantCONCEPTUS, INC.
PMA NumberP020014
Supplement NumberS018
Date Received05/27/2008
Decision Date03/16/2009
Product Code
HHS[ Registered Establishments with HHS ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
-
-