- Device
- Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S050
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2022-11-04
- Decision code
- APPR
- Date received
- 2022-10-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional control to ensure the spray coaters are running optimally during the manufacturing process.