|
Device | MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | MICROSULIS MEDICAL LTD. PARKLANDS BUSINESS PARK DENMEAD HAMPSHIRE PO7 6 |
PMA Number | P020031 |
Supplement Number | S002 |
Date Received | 07/12/2005 |
Decision Date | 10/14/2005 |
Withdrawal Date
|
07/05/2011 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISED PATIENT LABELING. |