PMA P100044S041
- Device
- Propel Contour Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S041
- Product code
- OWO
- Decision date
- 2019-05-31
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Alternate supplier for the raw fibers used in the manufacture of the Propel Contour Sinus Implant.
Current openFDA PMA Record#
- Device
- Propel Contour Sinus Implant
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S041
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2019-05-31
- Decision code
- OK30
- Date received
- 2019-05-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the raw fibers used in the manufacture of the Propel Contour Sinus Implant.