PMA P100044S030

Device: Mometasone Furoate Container Closure System
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S030
Product code: OWO
Decision date: 2017-09-27
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Addition of automated sealing equipment to add aluminum seals to the mometasone furoate (MF) container closure system utilized to store drug in the manufacturing area.

Current openFDA PMA Record#

Device: Mometasone Furoate Container Closure System
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S030
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2017-09-27
Decision code: OK30
Date received: 2017-08-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of automated sealing equipment to add aluminum seals to the mometasone furoate (MF) container closure system utilized to store drug in the manufacturing area.