|
Device | CONCEPTUS ESSURE SYSTEM |
Generic Name | Transcervical contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | BAYER PHARMA AG MOLLERSTRABE 178 BERLIN 13353 |
PMA Number | P020014 |
Supplement Number | S038 |
Date Received | 04/16/2012 |
Decision Date | 10/02/2012 |
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 A MATERIAL CHANGE AND A MINOR PROCESS CHANGE. THE USE OF NEW CARBOTHANE MATERIALS IN THE DELIVERY CATHETER WITH THE NEW HYDROPHILIC COATING AND A CHANGE IN OPERATING TEMPERATURE. |
Post-Approval Study | Show Report Schedule and Study Progress |