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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.
 
DeviceINTERSECTENT PROPEL MINI SINUS IMPLANT
Generic NameDrug-eluting sinus stent
ApplicantINTERSECT ENT
1555 ADAMS DR
MENLO PARK, CA 94025
PMA NumberP100044
Supplement NumberS008
Date Received03/04/2013
Decision Date07/17/2013
Product Code OWO 
Advisory Committee Ear Nose & Throat
Clinical TrialsNCT00840970
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Other
Expedited Review Granted? No
Combination ProductYes
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.
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