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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.
 
DeviceTHE CLOSER 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM AND THE CLOSER S 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS030
Date Received12/26/2000
Decision Date02/02/2001
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 FOR DESIGN CHANGES TO THE MULTI-LUMEN STRUCTURE OF THE SHEATH (FROM 5 LUMENS TO 3 LUMENS), AS WELL AS COMBINING THE EXIT RAMP AND PEBAX BEADING INTO A SINGLE INJECTION MOLDED PEBAX COMPONENT TO SIMPLIFY THE MANUFACTURING PROCESS. THESE MODIFICATIONS APPLY TO BOTH THE CLOSER 6 FR. SMC SYSTEM AND THE CLOSER S 6 FR. SMC SYSTEM.
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