|
Device | 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 | S051 |
Date Received | 04/04/2018 |
Decision Date | 04/09/2018 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the title of the "Patient-Doctor Discussion Checklist" to "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement,” and for revisions to the patient insert card. |
Approval Order | Approval Order |