PMA P020014S038

Device: CONCEPTUS ESSURE SYSTEM
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S038
Product code: HHS
Decision date: 2012-10-02
Generic name: Transcervical contraceptive tubal occlusion device
Approval order statement: APPROVAL FOR A MATERIAL CHANGE AND A MINOR PROCESS CHANGE. THE USE OF NEW CARBOTHANE MATERIALS IN THE DELIVERY CATHETER WITH THE NEW HYDROPHILIC COATING AND A CHANGE IN OPERATING TEMPERATURE.

Current openFDA PMA Record#

Device: CONCEPTUS ESSURE SYSTEM
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S038
Product code: HHS
Generic name: Transcervical contraceptive tubal occlusion device
Decision date: 2012-10-02
Decision code: APPR
Date received: 2012-04-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MATERIAL CHANGE AND A MINOR PROCESS CHANGE. THE USE OF NEW CARBOTHANE MATERIALS IN THE DELIVERY CATHETER WITH THE NEW HYDROPHILIC COATING AND A CHANGE IN OPERATING TEMPERATURE.