PMA P100044S052

Device: Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS)
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S052
Product code: OWO
Decision date: 2024-09-10
Classification: Ear, Nose, Throat
Generic name: Drug-eluting sinus stent
Approval order statement: replacement of the lot release residual solvent analytical testing requirement with annual testing

Current openFDA PMA Record#

Device: Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS)
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S052
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2024-09-10
Decision code: OK30
Date received: 2024-08-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: replacement of the lot release residual solvent analytical testing requirement with annual testing