|
Device | NovaSure Impedance Controlled Endometrial Ablation System |
Generic Name | Device, thermal ablation, endometrial |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P010013 |
Supplement Number | S085 |
Date Received | 10/04/2021 |
Decision Date | 01/04/2022 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a revision to the NovaSure post approval study protocol, S0112003. |