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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 AND PROPEL MINI SINUS IMPLANTS
Generic NameDrug-eluting sinus stent
ApplicantINTERSECT ENT
1555 ADAMS DR
MENLO PARK, CA 94025
PMA NumberP100044
Supplement NumberS019
Date Received09/30/2015
Decision Date10/28/2015
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
Approval Order Statement  
ADDING AN INCOMING QUALITY ASSURANCE TEST FOR SHRINKAGE OF THE FIBER COMPONENTS OF THE PROPEL AND PROPEL MINI PRODUCTS AND TO INCREASE THE UPPER LIMIT FOR THE INHERENT VISCOSITY (IV) MANUFACTURING LOT RELEASE SPECIFICATION TO MATCH THE UPPER LIMIT FOR THE CURRENT IV DESIGN SPECIFICATION.
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