PMA P100044S051

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: S051
Product code: OWO
Decision date: 2022-12-22
Generic name: Drug-eluting sinus stent
Approval order statement: Implementation of a new software system used 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: S051
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2022-12-22
Decision code: OK30
Date received: 2022-11-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new software system used to document, process, and store data for the spray coating manufacturing process for the Propel Sinus Implants.