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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 A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS044
Date Received03/03/2003
Decision Date04/04/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO: REPLACE THE BRAINED SUTURE WITH A MONOFILAMENT POLYPROPYLENE SUTURE; COMBINE THE INSTRUCTIONS FOR USE OF THE PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CHITO-SEAL DEVICE INTO A SINGLE PAMPHLET. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 8 FR. SHEATHS. THE PERCLOSE A-T MONOFILAMENT 6 FR. SMC SYSTEM REDUCES THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS.
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