PMA P100044S053

Device: Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S053
Product code: OWO
Decision date: 2024-10-02
Classification: Ear, Nose, Throat
Generic name: Drug-eluting sinus stent
Approval order statement: approval for upgrades to software system to document, process, and store data for the spray coating manufacturing process for the Propel Sinus Implants

Current openFDA PMA Record#

Device: Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S053
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2024-10-02
Decision code: OK30
Date received: 2024-09-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for upgrades to software system to document, process, and store data for the spray coating manufacturing process for the Propel Sinus Implants