PMA P020014S048

Device: ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S048
Product code: HHS
Decision date: 2016-12-14
Generic name: Transcervical contraceptive tubal occlusion device
Approval order statement: Establishment of a new site for manufacturing the delivery wire (component of the Essure delivery system) at 340 Lake Hazeltine Drive, Chaska, Minnesota.

Current openFDA PMA Record#

Device: ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S048
Product code: HHS
Generic name: Transcervical contraceptive tubal occlusion device
Decision date: 2016-12-14
Decision code: OK30
Date received: 2016-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Establishment of a new site for manufacturing the delivery wire (component of the Essure delivery system) at 340 Lake Hazeltine Drive, Chaska, Minnesota.