PMA P100044S056

Device: Propel®, Propel® Mini, Propel® Contour Sinus Implants
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S056
Product code: OWO
Decision date: 2025-02-12
Classification: Ear, Nose, Throat
Generic name: Drug-eluting sinus stent
Approval order statement: adding Medtronic North Haven Laboratory Services (Medtronic-North Haven) as an alternate test facility for in-process bioburden monitoring and periodic sterility testing of the Propel Product Family (Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant, and Propel Mini Sinus Implant with Straight Delivery System)

Current openFDA PMA Record#

Device: Propel®, Propel® Mini, Propel® Contour Sinus Implants
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S056
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2025-02-12
Decision code: OK30
Date received: 2025-01-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adding Medtronic North Haven Laboratory Services (Medtronic-North Haven) as an alternate test facility for in-process bioburden monitoring and periodic sterility testing of the Propel Product Family (Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant, and Propel Mini Sinus Implant with Straight Delivery System)