|
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 | S037 |
Date Received | 03/05/2012 |
Decision Date | 05/17/2012 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REPLACE THE CURRENT MANUAL DEPLOY AND DETACH TEST FIXTURE WITH AN AUTOMATED TEST FIXTURE FOR LOT RELEASE TESTING OF HE ESSURE SYSTEM. |