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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
Generic NameDrug-eluting sinus stent
ApplicantIntersect Ent.
1555 Adams Dr.
Menlo Park, CA 94025
PMA NumberP100044
Supplement NumberS020
Date Received03/25/2016
Decision Date08/24/2016
Product Code OWO 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Synergy Health AST, LLC, Lakevillle Hwy, Suite 120, Petaluma, CA 94954 as a backup sterilization facility for the Propel and Propel Mini Sinus Implants.
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