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.
 
DeviceCONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Generic NameTranscervical contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantBayer Pharma AG
Mollerstrabe 178
Berlin 13353
PMA NumberP020014
Supplement NumberS025
Date Received05/11/2009
Decision Date06/11/2009
Product Code HHS 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE MANUFACTURING OF THE MECHANISM THAT HOLDS THE INNER CATHETER SUBASSEMBLY RELEASE RIBBON IN PLACE.
-
-