PMA P020014S046

Device: ESSURE SYSTEM
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S046
Product code: HHS
Decision date: 2016-11-15
Generic name: Transcervical contraceptive tubal occlusion device
Approval order statement: Approval for changes to the physicians instructions for use and patient information booklet including a boxed warning and a patient decision checklist.

Current openFDA PMA Record#

Device: ESSURE SYSTEM
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S046
Product code: HHS
Generic name: Transcervical contraceptive tubal occlusion device
Decision date: 2016-11-15
Decision code: APPR
Date received: 2016-05-19
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changes to the physicians instructions for use and patient information booklet including a boxed warning and a patient decision checklist.