PMA P100044S036

Device: Propel Family of Sinus Implants
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S036
Product code: OWO
Decision date: 2019-01-10
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Approval for extending the storage shelf life of the component fibers used in the manufacture of the Propel Family of Sinus Implants (Propel, Propel Mini, Propel Contour) to 20 months.

Current openFDA PMA Record#

Device: Propel Family of Sinus Implants
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S036
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2019-01-10
Decision code: APPR
Date received: 2018-10-12
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for extending the storage shelf life of the component fibers used in the manufacture of the Propel Family of Sinus Implants (Propel, Propel Mini, Propel Contour) to 20 months.