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)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceESSURE SYSTEM
Generic NameTranscervical contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantBAYER PHARMA AG
MOLLERSTRABE 178
BERLIN 13353
PMA NumberP020014
Supplement NumberS005
Date Received11/10/2003
Decision Date06/10/2004
Product Code HHS 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE DEVICE LABELING TO INCLUDE 3-YEAR EFFECTIVENESS RESULTS AND OTHER LABELING CHANGES.
-
-