|
Device | CONCEPTUS 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 | S003 |
Date Received | 03/13/2003 |
Decision Date | 04/11/2003 |
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 LABELING CHANGES TO ADDRESS THE DIFFICULTY/FAILURE TO DISENGAGE OR DETACH THE DELIVERY WIRE FROM THE ESSURE MICRO-INSERT AND LABELING CHANGES TO STRENGTHEN THE RECOMMENDATION REGARDING USE OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) PRIOR TO THE ESSURE PROCEDURE. |
Post-Approval Study | Show Report Schedule and Study Progress |