|
Device | CONCEPTUS ESSURE 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 | S020 |
Date Received | 07/23/2008 |
Decision Date | 09/11/2008 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO SPECIFICATIONS OF THE DRY FLOW INTRODUCER AND THE ADDITION OF A BACK-UP BOND IN THE DETACHMENT MECHANISM. |
Post-Approval Study | Show Report Schedule and Study Progress |