|
Device | ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL |
Generic Name | Transcervical contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | BAYER PHARMA AG MOLLERSTRABE 178 BERLIN 13353 |
PMA Number | P020014 |
Supplement Number | S048 |
Date Received | 11/21/2016 |
Decision Date | 12/14/2016 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |