PMA P100044S025

Device: PROPEL SINUS, MINI SINUS IMPLANT.
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S025
Product code: OWO
Decision date: 2016-10-28
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Modify the incoming quality assurance test method and associated acceptance criteria for the tensile test for the monofilament fiber component in Propel and Propel Mini Sinus Implants.

Current openFDA PMA Record#

Device: PROPEL SINUS, MINI SINUS IMPLANT.
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S025
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2016-10-28
Decision code: OK30
Date received: 2016-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modify the incoming quality assurance test method and associated acceptance criteria for the tensile test for the monofilament fiber component in Propel and Propel Mini Sinus Implants.