PMA P100044S027

Device: Propel Sinus Implant & Propel mini Sinus Implant
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S027
Product code: OWO
Decision date: 2017-05-30
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Approval for the implementation of mechanically interlocking bond joints for the Propel and Propel Mini delivery systems, as well as a redefined tensile strength specification for the Propel applicator.

Current openFDA PMA Record#

Device: Propel Sinus Implant & Propel mini Sinus Implant
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S027
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2017-05-30
Decision code: APPR
Date received: 2017-03-01
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the implementation of mechanically interlocking bond joints for the Propel and Propel Mini delivery systems, as well as a redefined tensile strength specification for the Propel applicator.