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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.
 
DevicePROPEL SINUS IMPLANT, PROPEL MINI SINUS IMPLANT
Generic NameDrug-eluting sinus stent
ApplicantIntersect Ent.
1555 Adams Dr.
Menlo Park, CA 94025
PMA NumberP100044
Supplement NumberS010
Date Received06/25/2013
Decision Date08/13/2013
Product Code OWO 
Advisory Committee Ear Nose & Throat
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) AND LABELS THAT ENHANCE THE SAFETY IN THE USE OF THE PROPEL AND PROPEL MINI SINUS IMPLANTS.
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