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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.
 
DeviceBIODIVYSIO AS OTW
Generic NameSTENT, CORONARY
ApplicantAbbott Vascular, Inc.
26531 Ynez Rd., Bldg. G, Mailing P.O. 9018
Temecula, CA 92590
PMA NumberP000011
Supplement NumberS005
Date Received09/24/2001
Decision Date10/22/2001
Withdrawal Date09/05/2014
Product Code MAF 
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  
AMENDING EXISTING PROCEDURES TO IMPROVE THE INSPECTION OF STENTS AFTER LASER CUTTING, PRIOR TO AND AFTER ELECTROPOLISHING; AND ADDITION OF THE UNIVERSAL STENT CRIMPER.
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