PMA P020014S021

Device: ESSURE SYSTEM
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S021
Product code: HHS
Decision date: 2008-11-07
Generic name: Transcervical contraceptive tubal occlusion device
Approval order statement: APPROVAL FOR MINOR DESIGN CHANGES TO THE ESSURE SYSTEM, I.E., DIMENSIONAL SPECIFICATION OF THE DELIVERY WIRE HOLDER; CHANGE TO THE RELEASE BAND POSITIONING; AND A CHANGE TO THE HEAT SHRINK TUBING LENGTH.

Current openFDA PMA Record#

Device: ESSURE SYSTEM
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S021
Product code: HHS
Generic name: Transcervical contraceptive tubal occlusion device
Decision date: 2008-11-07
Decision code: APPR
Date received: 2008-09-11
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MINOR DESIGN CHANGES TO THE ESSURE SYSTEM, I.E., DIMENSIONAL SPECIFICATION OF THE DELIVERY WIRE HOLDER; CHANGE TO THE RELEASE BAND POSITIONING; AND A CHANGE TO THE HEAT SHRINK TUBING LENGTH.