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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceGENESYS HTA SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantAxora Medical, Inc.
1 Independent Dr. Suite 2300
Jacksonville, FL 32202
PMA NumberP000040
Supplement NumberS016
Date Received06/14/2010
Decision Date07/08/2010
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
IMPLEMENTATION OF AN INSPECTION AT THE CASSETTE MANUFACTURER AND AN UPDATE TO A SUBASSEMBLY DRAWING.
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