Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S011 |
Date Received | 09/08/2004 |
Decision Date | 03/07/2005 |
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 REVISED INSTRUCTIONS FOR USE, INCLUDING RESULTS FROM THE THREE-YEAR FOLLOW UP, IMPROVED CONSISTENCY, AND A REVISION TO THE CONTRAINDICATIONS REGARDING LONG-TERM MEDICAL THERAPY. |
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