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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(TM) AND THE CLOSER S(TM) DEVICES
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS028
Date Received11/13/2000
Decision Date12/12/2000
Advisory Committee Cardiovascular
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  
REDUCING THE SHEATH TO GUIDE TENSILE STRENGTH ACCEPTANCE CRITERIA TO A MINIMUM OF 5 LBF. FROM 7 LBF.
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