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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.
 
DeviceINVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM
Generic NameAutomated breast ultrasound
ApplicantGE Healthcare
9900 Innovation Dr.
Wauwatosa, WI 53226
PMA NumberP110006
Supplement NumberS006
Date Received09/18/2015
Decision Date10/15/2015
Product Code PAA 
Advisory Committee Radiology
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  
CHANGES IN SUPPLIERS FOR 12 CRITICAL PARTS, TO IMPROVE THE PARTS' QUALITY, PRODUCTIVITY, AND DELIVERY. THE COMMON CHARACTERISTIC OF ALL 12 PARTS IS THEIR ELECTRICAL CONDUCTIVITY ON SPECIFIED SURFACES, TO ALLOW ELECTRICAL CONTINUITY FOR PROPER GROUNDING OF YOUR DEVICE. THE PROPOSED CHANGES DO NOT INVOLVE ANY CHANGES IN THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.
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