PMA P100044S058
- Device
- Propel Contour Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S058
- Product code
- OWO
- Decision date
- 2025-11-07
- Classification
- Ear, Nose, Throat
- 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