|
Device | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL |
Generic Name | Transcervical contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | BAYER PHARMA AG MOLLERSTRABE 178 BERLIN 13353 |
PMA Number | P020014 |
Supplement Number | S012 |
Date Received | 03/17/2006 |
Decision Date | 06/15/2007 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN AND MATERIAL CHANGES TO THE MICRO-INSERT, DELIVERY CATHETER, AND INTRODUCER OF THE ESSURE SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |