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Device | Minerva Endometrial Ablation System |
Generic Name | Device, thermal ablation, endometrial |
Applicant | MINERVA SURGICAL 101 SAGINAW DRIVE REDWOOD CITY, CA 94063 |
PMA Number | P140013 |
Supplement Number | S011 |
Date Received | 01/13/2020 |
Decision Date | 02/12/2020 |
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 change to your new facility located at Minerva Surgical, 4255 Burton Drive, Santa Clara, California. The facility operations at this site involve the manufacturing of the Minerva Endometrial Ablation System Disposable Handpiece. |