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 | GENESYS HTA SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | Minerva Surgical, Inc. 4255 Burton Drive Santa Clara, CA 95054 |
PMA Number | P000040 |
Supplement Number | S030 |
Date Received | 04/10/2013 |
Decision Date | 07/19/2013 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE GOLD THICKNESS SPECIFICATION OF THE CASSETTE CONTACT PINS FROM FLASH GOLD TO >= 15 MICRON-INCHES AND A MODIFICATION TO THE SHIPPER TRAY SO THAT THE CONTACT PINS DO NOT CONTACT ITS LID. |
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