|
Device | NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P010013 |
Supplement Number | S023 |
Date Received | 04/08/2009 |
Decision Date | 05/08/2009 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES INTENDED TO IMPROVE THE INSTRUCTIONS FOR USE IN REGARD TO SAFE REMOVAL OF THE NOVASURE DEVICE FOLLOWING TREATMENT. |