PMA P100044S054

Device: Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System, Propel Contor
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S054
Product code: OWO
Decision date: 2024-10-11
Classification: Ear, Nose, Throat
Generic name: Drug-eluting sinus stent
Approval order statement: adding new identity testing for existing packaging components, as applicable, during incoming inspection before approval for production use, and adding a new test facility to conduct this identity testing

Current openFDA PMA Record#

Device: Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System, Propel Contor
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S054
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2024-10-11
Decision code: OK30
Date received: 2024-09-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding new identity testing for existing packaging components, as applicable, during incoming inspection before approval for production use, and adding a new test facility to conduct this identity testing