|
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 | S004 |
Date Received | 05/21/2003 |
Decision Date | 07/17/2003 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR NEW EXPIRATION DATES FOR THE GAMMA CATHETER (WITH PACKAGING PROCESS IMPROVEMENTS) AND THE COIL CATHETER (WITH PACKAGING PROCESS IMPROVEMEMENTS.) |