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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.
 
DeviceACCULINK, RX
Classification Namestent, carotid
Generic Namestent, carotid
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP040012
Supplement NumberS045
Date Received05/24/2012
Decision Date06/21/2012
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING.
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