PMA P100044S042
- Device
- Propel, Propel Mini and Propel Contour Sinus Implants
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S042
- Product code
- OWO
- Decision date
- 2019-06-27
- Classification
- Drug-eluting Sinus Stent
- Generic name
- Drug-eluting sinus stent
- Approval order statement
- Modification of incoming quality assurance inspection criteria and titles for the packaging tray and lid components.
Current openFDA PMA Record#
- Device
- Propel, Propel Mini and Propel Contour Sinus Implants
- Applicant
- Intersect Ent.
- PMA number
- P100044
- Supplement
- S042
- Product code
- OWO
- Generic name
- Drug-eluting sinus stent
- Decision date
- 2019-06-27
- Decision code
- OK30
- Date received
- 2019-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of incoming quality assurance inspection criteria and titles for the packaging tray and lid components.