|
Device | 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 | S008 |
Date Received | 09/20/2004 |
Decision Date | 01/31/2005 |
Product Code |
HHS |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A PROPOSED PACKAGING MODIFICATION AND SUBSEQUENT CHANGES TO THE ETHYLENE OXIDE (EO) STERILIZATION CYCLE AND SHELF LIFE VALIDATION STUDY. |