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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.
Classification Namedrug-eluting sinus stent
Generic Namedrug-eluting sinus stent
1555 adams dr
menlo park, CA 94025
PMA NumberP100044
Supplement NumberS008
Date Received03/04/2013
Decision Date07/17/2013
Product Code
OWO[ Registered Establishments with OWO ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track no user fee
Supplement Reason other report
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Agreed to the recommendation to revise the stability protocol to reflect the drug release acceptance criteria of ± 12% of the target value used for product release.