Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HTA SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | Minerva Surgical, Inc. 4255 Burton Drive Santa Clara, CA 95054 |
PMA Number | P000040 |
Supplement Number | S013 |
Date Received | 02/13/2009 |
Decision Date | 05/14/2009 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE HTA PROCEDURE SHEATH (A COMPONENT OF THE HTA SYSTEM) WHICH INCLUDE THE ADDITION OF THE CERVICAL SEAL ASSIST COMPONENT AND A REDESIGN OF THE RESERVOIR TIP. THE SHEATH, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTA PROCERVA PROCEDURE SHEATH. |
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