|
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 | S050 |
Date Received | 09/11/2013 |
Decision Date | 11/08/2013 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |