PMA P100044

Device
Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel Contour Sinus Implants
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S051
Product code
OWO
Decision date
2026-07-31
Generic name
Drug-eluting sinus stent
Approval order statement
approval for an alternate analytical testing site for analytical lot release and stability testing for the Propel family of products

Current openFDA PMA Record#

Device
Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel Contour Sinus Implants
Applicant
Intersect Ent.
PMA number
P100044
Supplement
S059
Product code
OWO
Generic name
Drug-eluting sinus stent
Decision date
2026-07-31
Decision code
APPR
Date received
2026-06-05
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for an alternate analytical testing site for analytical lot release and stability testing for the Propel family of products