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 EDOMETRIAL ABLATION SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P010013 |
Supplement Number | S058 |
Date Received | 07/27/2014 |
Decision Date | 10/28/2014 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DEVICE MODIFICATIONS, INCLUDING FLATTENING OF THE NVSRAM BATTERY CLIP AND ADDITION OF KAPTON TAPE TO THE NVSRAM BATTERY AND THE UI BOARD SHIELD TO OVERCOME A DEVICE ERROR OCCURRING IF CONTACT OF THESE COMPONENTS OCCURS. |
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