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 | S022 |
Date Received | 01/12/2012 |
Decision Date | 02/14/2012 |
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 ADDITION OF A NEW SUPPLIER IN THE MANUFACTURING PROCESS. |
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