|
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 | S017 |
Date Received | 04/04/2008 |
Decision Date | 02/24/2012 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE EXISTING RF ENERGY WARNING TO ADD AN ESSURE/ NOVASURE WARNING. ADDITIONALLY, THE PMA SUPPLEMENT INCLUDES APPROVAL OF A POST-APPROVAL STUDY. |
Post-Approval Study | Show Report Schedule and Study Progress |