PMA P100044S049
- Device
- Propel Contour Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S049
- Product code
- OWO
- Decision date
- 2022-06-24
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Approval for the change of e-beam sterilization dose for the Propel Contour Sinus Implant.
Current openFDA PMA Record#
- Device
- Propel Contour Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S049
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2022-06-24
- Decision code
- APPR
- Date received
- 2022-03-28
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the change of e-beam sterilization dose for the Propel Contour Sinus Implant.