|
Device | 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 | S038 |
Date Received | 04/25/2019 |
Decision Date | 07/24/2019 |
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 introduction of a delivery system with a straight applicator for ethmoid sinus access and serves as an alternative to the approved delivery system with a curved applicator. |