PMA P100044

Device
Propel Contour Sinus Implant
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S051
Product code
OWO
Decision date
2025-11-07
Generic name
Drug-eluting sinus stent
Approval order statement
to designate pre-deployment dimensional specifications as reference values for the Propel Contour Sinus Implant

Current openFDA PMA Record#

Device
Propel Contour Sinus Implant
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S058
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2025-11-07
Decision code
APPR
Date received
2025-08-11
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
to designate pre-deployment dimensional specifications as reference values for the Propel Contour Sinus Implant