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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DevicePHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO SV AND OC OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS
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 NumberS010
Date Received08/14/2003
Decision Date11/05/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the compliance charts to enhance the accuracy of the labeling for the pc coated biodivysio sv and oc otw stent delivery systems.
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