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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 Contour Sinus Implant
Generic NameDrug-eluting sinus stent
ApplicantIntersect Ent.
1555 Adams Dr.
Menlo Park, CA 94025
PMA NumberP100044
Supplement NumberS040
Date Received05/01/2019
Decision Date05/31/2019
Product Code OWO 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to the in-process acceptance criterion for the mometasone furoate (MF) coating solution assay from a concentration range of 5.9- 6.2 mg/mL to 5.8- 6.1 mg/mL to align with the manufacturing target and lot history data.
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