PMA P100044S057
- Device
- PROPEL, PROPEL MINI and PROPEL CONTOUR
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S057
- Product code
- OWO
- Decision date
- 2025-06-18
- Classification
- Ear, Nose, Throat
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- removal of Mometasone Furoate (MF) concentration testing as an in-process requirement from the Propel, Propel Mini, and Propel Contour manufacturing processes
Current openFDA PMA Record#
- Device
- PROPEL, PROPEL MINI and PROPEL CONTOUR
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S057
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2025-06-18
- Decision code
- OK30
- Date received
- 2025-05-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of Mometasone Furoate (MF) concentration testing as an in-process requirement from the Propel, Propel Mini, and Propel Contour manufacturing processes