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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.
 
DevicePROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR INC.
400 saginaw drive
redwood city, CA 94063
PMA NumberP960043
Supplement NumberS073
Date Received06/30/2011
Decision Date08/24/2011
Product Code
MGB[ Registered Establishments with MGB ]
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 changes to your packaging and packaging integrity testing.
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