PMA P100044S055
- Device
- Propel® Contour Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S055
- Product code
- OWO
- Decision date
- 2024-11-25
- Classification
- Ear, Nose, Throat
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- replacement of the lot release residual solvent analytical testing requirement with annual testing
Current openFDA PMA Record#
- Device
- Propel® Contour Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S055
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2024-11-25
- Decision code
- OK30
- Date received
- 2024-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- replacement of the lot release residual solvent analytical testing requirement with annual testing