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 | HTA SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | Minerva Surgical, Inc. 4255 Burton Drive Santa Clara, CA 95054 |
PMA Number | P000040 |
Supplement Number | S010 |
Date Received | 03/29/2007 |
Decision Date | 08/08/2007 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT NEXCORE TECHNOLOGY, INC., WALDWICK, NEW JERSEY TO MANUFACTURE THE FOLLOWING COMPONENTS: HTA SYSTEM CONSOLE, REUSABLE HEATER CANISTER, AND SCOPE ADAPTER. |
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