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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 | S015 |
Date Received | 01/03/2024 |
Decision Date | 01/24/2024 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an update to a manufacturing procedure to provide an additional requirement for the silicone tubing for the Minerva ES Handpiece. |