Premarket Approval (PMA)

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.

• Device: PROPEL AND PROPEL MINI SINUS IMPLANTS
• Generic Name: Drug-eluting sinus stent
• Applicant: INTERSECT ENT; 1555 ADAMS DR; MENLO PARK, CA 94025
• PMA Number: P100044
• Supplement Number: S015
• Date Received: 01/16/2014
• Decision Date: 02/11/2014
• Product Code: OWO
• Advisory Committee: Ear Nose & Throat
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
ALTERNATE SUPPLIER BE CLEARED.