PMA P100044S026

Device: PROPEL SINUS IMPLANT & PROPEL MINI SINUS IMPLANT
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S026
Product code: OWO
Decision date: 2017-01-27
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Addition of a new semi-automated heating/cooling system and implementation of new curing temperatures and times used to form the applicators of the implant delivery systems.

Current openFDA PMA Record#

Device: PROPEL SINUS IMPLANT & PROPEL MINI SINUS IMPLANT
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S026
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2017-01-27
Decision code: OK30
Date received: 2016-12-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a new semi-automated heating/cooling system and implementation of new curing temperatures and times used to form the applicators of the implant delivery systems.