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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, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C
Generic NameDrug-eluting sinus stent
ApplicantIntersect Ent.
1555 Adams Dr.
Menlo Park, CA 94025
PMA NumberP100044
Supplement NumberS050
Date Received10/05/2022
Decision Date11/04/2022
Product Code OWO 
Advisory Committee Ear Nose & Throat
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional control to ensure the spray coaters are running optimally during the manufacturing process.
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