|
Device | Propel Family of Sinus Implants |
Generic Name | Drug-eluting sinus stent |
Applicant | INTERSECT ENT 1555 ADAMS DR MENLO PARK, CA 94025 |
PMA Number | P100044 |
Supplement Number | S045 |
Date Received | 03/26/2020 |
Decision Date | 04/24/2020 |
Product Code |
OWO |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for modifications to the Instructions for Use (IFU) to enhance the safe use of the Propel Family of Implants (Propel, Propel Mini and Propel Contour). |