PMA P100044S032

Device: Propel, Propel mini and Propel Contour Sinus Implants
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S032
Product code: OWO
Decision date: 2018-06-01
Classification: Drug-eluting Sinus Stent
Generic name: Drug-eluting sinus stent
Approval order statement: Modification of the pneumatic crimper used in the manufacturing of the delivery systems for the Propel, Propel mini and Propel Contour Sinus Implants.

Current openFDA PMA Record#

Device: Propel, Propel mini and Propel Contour Sinus Implants
Applicant: Intersect Ent.
PMA number: P100044
Supplement: S032
Product code: OWO
Generic name: Drug-eluting sinus stent
Decision date: 2018-06-01
Decision code: OK30
Date received: 2018-05-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification of the pneumatic crimper used in the manufacturing of the delivery systems for the Propel, Propel mini and Propel Contour Sinus Implants.