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 | S002 |
Date Received | 05/08/2002 |
Decision Date | 06/05/2002 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFICATIONS TO THE MANUFACTURING PROCESSES FOR THE NOVASURE DISPOSABLE DEVICE, INCLUDING INJECTION MOLDING OF THE PLASTIC COMPONENTS, INCORPORATION OF THE NON-CONDUCTING LINES OF THE ARRAY INTO THE PEAK II KNITTING PROCESS, AND THE INCORPORATION OF THREE SEPARATE TUBES INTO A SINGLE MULTI-LUMEN EXTRUSION. |
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