|
Device | ESSURE PERMANENT BIRTH CONTROL SYSTEM |
Generic Name | Transcervical contraceptive tubal occlusion device |
Regulation Number | 884.5380 |
Applicant | BAYER PHARMA AG MOLLERSTRABE 178 BERLIN 13353 |
PMA Number | P020014 |
Supplement Number | S013 |
Date Received | 07/17/2006 |
Decision Date | 09/19/2006 |
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. |
Post-Approval Study | Show Report Schedule and Study Progress |