|
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 | S029 |
Date Received | 10/13/2009 |
Decision Date | 04/06/2010 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATED MICRO-INSERT PLACEMENT RATES IN THE PHYSICIAN LABELING RESULTING FROM THE ESS305 POST-APPROVAL STUDY. |