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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.
 
DevicePERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS049
Date Received10/27/2003
Decision Date11/25/2003
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. THESE CHANGES STRENGTHEN THE PROCEDURAL INSTRUCTIONS FOR USING THE DEVICE AND ADD A PRECAUTION TO NOT USE EXCESSIVE FORCE OR TORQUE TO ADVANCE THE DEVICE, STATING THAT SUCH ACTIONS MAY RESULT IN: "IGNIFICANT ARTERIAL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE SURGICAL REMOVAL OF THE DEVICE AND ARTERIAL REPAIR." IN ADDITION TO THESE LABELING CHANGES, YOU HAVE ALSO INDICATED THAT THE PHYSICIAN TRAINING PROTOCOL HAS BEEN REVISED TO FURTHER ADDRESS THIS CONCERN.
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