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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.
 
DevicePHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR INC.
26531 ynez road, building g
mailing p.o. 9018
temecula, CA 92590-9018
PMA NumberP000011
Supplement NumberS009
Date Received07/01/2003
Decision Date12/08/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF AN 8 MM STENT IN DIAMETERS OF 3.0, 3.5, AND 4.0 MM FOR THE BIODIVYSIO OC OTW SYSTEM.
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