PMA P100044S035

Device: Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S035
Product code: OWO
Decision date: 2018-09-21
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Extending the shelf life of the drug coating solution used in the manufacture of the Propel family of sinus implants, and to scale up the solution storage volume.

Current openFDA PMA Record#

Device: Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S035
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2018-09-21
Decision code: OK30
Date received: 2018-08-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Extending the shelf life of the drug coating solution used in the manufacture of the Propel family of sinus implants, and to scale up the solution storage volume.