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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.
 
DeviceMYNX VASCULAR CLOSURE DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP040044
Supplement NumberS015
Date Received06/25/2009
Decision Date07/13/2009
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE. SPECIFICALLY, TO INCLUDE A 10 SECOND AND 60 SECOND WAIT TIME FOR DIAGNOSTIC AND INTERVENTIONAL PROCEDURES RESPECTIVELY, PRIOR TO DEFLATING AND REMOVING THE BALLOON CATHETER.
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