|
Device | ESSURE |
Generic Name | Transcervical contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | BAYER PHARMA AG MOLLERSTRABE 178 BERLIN 13353 |
PMA Number | P020014 |
Supplement Number | S040 |
Date Received | 10/03/2013 |
Decision Date | 10/30/2013 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BOOKLET TO INCLUDE ADDITIONAL INFORMATION ON RISKS OF CHRONIC PELVIC PAIN AND DEVICE MIGRATION. |