|
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
|