|
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 | S007 |
Date Received | 03/24/2004 |
Decision Date | 04/08/2004 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT VENUSA, LTD., CHIHUAHUA, MEXICO. |
Post-Approval Study | Show Report Schedule and Study Progress |