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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.
 
DeviceRX ZETA, OTW ZETA
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR INC.
26531 ynez road
temecula, CA 92591
PMA NumberP970020
Supplement NumberS071
Date Received02/06/2012
Decision Date03/07/2012
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the balloon manufacturing process.
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