|
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 | S049 |
Date Received | 11/20/2017 |
Decision Date | 12/04/2017 |
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 Change in a supplier's site of manufacture of the wound coil, inner coil and outer coil critical components from Tualatin Oregon to Heredia, Costa Rica. |