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. |
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Device | Propel Sinus Implant & Propel mini Sinus Implant |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S027 |
Date Received | 03/01/2017 |
Decision Date | 05/30/2017 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the implementation of mechanically interlocking bond joints for the Propel and Propel Mini delivery systems, as well as a redefined tensile strength specification for the Propel applicator. |
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