FDA.reportPublic FDA data

PMA P020014

Device
Essure System for Permanent Birth Control
Applicant
Bayer Pharma AG
PMA number
P020014
Supplement
S051
Product code
HHS
Decision date
2018-04-09
Classification
Transcervical Contraceptive Tubal Occlusion Device
Generic name
Transcervical contraceptive tubal occlusion device
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.

Current openFDA PMA Record#

Device
Essure System for Permanent Birth Control
Applicant
Bayer Pharma AG
PMA number
P020014
Supplement
S051
Product code
HHS
Generic name
Transcervical contraceptive tubal occlusion device
Decision date
2018-04-09
Decision code
APPR
Date received
2018-04-04
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
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.