|
Device | MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) |
Generic Name | Device, thermal ablation, endometrial |
Applicant | MICROSULIS MEDICAL LTD. PARKLANDS BUSINESS PARK DENMEAD HAMPSHIRE PO7 6 |
PMA Number | P020031 |
Supplement Number | S003 |
Date Received | 04/11/2008 |
Decision Date | 09/02/2008 |
Withdrawal Date
|
07/05/2011 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE FOR THE MEA SYSTEM TO INCLUDE THE RESULTS OF THE LONG-TERM FOLLOW-UP OF STUDY SUBJECTS. |