|
Device | HYDRO THERMABLATOR. ENDOMETRIAL ABLATION SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | Minerva Surgical, Inc. 4255 Burton Drive Santa Clara, CA 95054 |
PMA Number | P000040 |
Supplement Number | S002 |
Date Received | 10/09/2001 |
Decision Date | 12/07/2001 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USING MOLDING AND EXTRUDING TECHNIQUES RATHER THAN MACHINING THE COMPONENTS THAT NMAKE UP THE DISPOSABLE SHEATH OF THE HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM. |